CompletedPhase 1Results posted
Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity
A PHASE 1, OPEN -LABEL, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF TWO STEADY STATE DOSE LEVELS OF PF-06882961 ON THE PHARMACOKINETICS OF SINGLE ORAL DOSES OF ROSUVASTATIN AND MIDAZOLAM IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OBESITY
Lead sponsor
Asset
Danuglipron
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Actual enrollment
16
Study population
Obesity / overweight
Eligibility highlights
•BMI ≥30
Primary endpoints
•Area Under the Plasma Concentration-time Profile From Time 0 to Last•AUClast of Midazolam in Periods 2, 5 and 8
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
NCT IDNCT04621227
Org study IDC3421007
Timeline
Milestones
Study first posted2020-11-09actual
Study start2020-12-15actual
Primary completion2021-05-13actual
Study completion2021-05-13actual
Last update posted2023-12-01actual
Results first posted2023-12-01actual
Assets
Investigational agents
Who this study enrolls
Obesity / overweight
Who can enroll
Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Body Mass Index (BMI) ≥ 30.0 kg/m2 and not more than 45.4 kg/m2 at Screening.
•Stable body weight, defined as <5 kg change (per participant report) for 90 days before Screening
Exclusion criteria
•Known prior participation in a trial involving PF-06882961.
•Known intolerance or hypersensitivity to GLP-1R agonists.
•Known hypersensitivity to rosuvastatin or midazolam.
•Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at screening. Note: prior diagnoses of gestational diabetes during pregnancy only are eligible if they meet the other eligibility criteria
•Any lifetime history of a suicide attempt.
•Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
•Participation in a formal weight reduction program (eg, Weight Watchers) within 90 days prior to Screening.
Endpoints (18)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
14
Weight & body composition
2
Patient-reported / QoL
2
Weight & body composition
2 endpointsSecondary/registry result
Change From Baseline in Body Weight
Time frame:At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15 and 22, Period 4 Day 1, Period 6 Days 1 and 9, Period 7 Day 1, Period 8 Day 2, and at Follow Up visit (Days 68-71)
change from baseline, improvement
Posted result
| Group | Mean · kilogram (kg) | 95% CI |
|---|---|---|
| All ParticipantsPeriod 3 Day 1 / PF-06882961 titration up to 120 mg BID | -1.5 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120 mg BID | -1.9 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120 mg BID | -3.3 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120 mg BID | -4.3 | - |
| Period 4 Day 1 / PF-06882961 120 mg BID + rosuvastatin 10 mg | -5.2 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200 mg BID | -6.1 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200 mg BID | -7.5 | - |
| Period 7 Day 1 / PF-06882961 200 mg BID + rosuvastatin 10 mg | -9.1 | - |
| Period 8 Day 2 / PF-06882961 200 mg BID + midazolam 2 mg | -9.9 | - |
| Follow up | -5.7 | - |
Secondary/protocol endpoint
Change From Baseline in Body Weight
Time frame:At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15 and 22, Period 4 Day 1, Period 6 Days 1 and 9, Period 7 Day 1, Period 8 Day 2, and at Follow Up visit (Days 68-71)
Body weight, absolute change (kg)
change from baseline, improvement
Patient-reported / QoL
2 endpointsSecondary/registry result
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Time frame:At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15, and 22, Period 4 Day 1, Period 6 Days 1, 9, and 16, Period 8 Day 2, at Follow Up visit (Days 68-71) and Early Termination
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| All ParticipantsBL Little Interest/Pleasure in Things | 16 | - |
| BL Little Interest/Pleasure in Things | 0 | - |
| BL Little Interest/Pleasure in Things | 0 | - |
| BL Little Interest/Pleasure in Things | 0 | - |
| BL Feeling Down Depressed or Hopeless | 16 | - |
| BL Feeling Down Depressed or Hopeless | 0 | - |
| BL Feeling Down Depressed or Hopeless | 0 | - |
| BL Feeling Down Depressed or Hopeless | 0 | - |
| BL Trouble Falling or Staying Asleep | 16 | - |
| BL Trouble Falling or Staying Asleep | 0 | - |
| BL Trouble Falling or Staying Asleep | 0 | - |
| BL Trouble Falling or Staying Asleep | 0 | - |
| BL Feeling Tired or Little Energy | 16 | - |
| BL Feeling Tired or Little Energy | 0 | - |
| BL Feeling Tired or Little Energy | 0 | - |
| BL Feeling Tired or Little Energy | 0 | - |
| BL Poor Appetite or Overeating | 15 | - |
| BL Poor Appetite or Overeating | 1 | - |
| BL Poor Appetite or Overeating | 0 | - |
| BL Poor Appetite or Overeating | 0 | - |
| BL Feeling Bad About Yourself | 16 | - |
| BL Feeling Bad About Yourself | 0 | - |
| BL Feeling Bad About Yourself | 0 | - |
| BL Feeling Bad About Yourself | 0 | - |
| BL Trouble Concentrating on Things | 16 | - |
| BL Trouble Concentrating on Things | 0 | - |
| BL Trouble Concentrating on Things | 0 | - |
| BL Trouble Concentrating on Things | 0 | - |
| BL Moving Slowly or Fidgety/Restless | 16 | - |
| BL Moving Slowly or Fidgety/Restless | 0 | - |
| BL Moving Slowly or Fidgety/Restless | 0 | - |
| BL Moving Slowly or Fidgety/Restless | 0 | - |
| BL Thoughts You Be Better Off Dead | 16 | - |
| BL Thoughts You Be Better Off Dead | 0 | - |
| BL Thoughts You Be Better Off Dead | 0 | - |
| BL Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 1/PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 16 | - |
| Period 3 Day 1/PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 1/PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 1/PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 16 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 16 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 15 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 1 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 16 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 16 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 16 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 16 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 16 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 15 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 15 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 14 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 1 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 15 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 14 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 1 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 15 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 15 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 15 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 15 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 14 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 1 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 15 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 14 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 1 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 14 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 1 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 13 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 2 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 15 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 15 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 15 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 15 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 14 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 14 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 14 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 13 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 1 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 11 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 3 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 14 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 14 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 14 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 14 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Little Interest/Pleasure in Things | 14 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Little Interest/Pleasure in Things | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Down Depressed or Hopeless | 13 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Down Depressed or Hopeless | 1 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Down Depressed or Hopeless | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Falling or Staying Asleep | 14 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Falling or Staying Asleep | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Tired or Little Energy | 11 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Tired or Little Energy | 3 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Tired or Little Energy | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Tired or Little Energy | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Poor Appetite or Overeating | 12 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Poor Appetite or Overeating | 2 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Poor Appetite or Overeating | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Poor Appetite or Overeating | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Bad About Yourself | 14 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Bad About Yourself | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Bad About Yourself | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Bad About Yourself | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Concentrating on Things | 14 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Concentrating on Things | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Concentrating on Things | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Concentrating on Things | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Moving Slowly or Fidgety/Restless | 14 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Moving Slowly or Fidgety/Restless | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Thoughts You Be Better Off Dead | 14 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Thoughts You Be Better Off Dead | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things | 14 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless | 14 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep | 12 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep | 2 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy | 13 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy | 1 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating | 11 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating | 3 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself | 14 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things | 13 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things | 1 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless | 14 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead | 14 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things | 14 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless | 14 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep | 14 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy | 13 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy | 1 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating | 12 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating | 2 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself | 14 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things | 14 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless | 14 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead | 14 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things | 14 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless | 14 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep | 14 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy | 11 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy | 3 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating | 13 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating | 1 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself | 14 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things | 14 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless | 14 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead | 14 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Little Interest/Pleasure in Things | 14 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Little Interest/Pleasure in Things | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Little Interest/Pleasure in Things | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Little Interest/Pleasure in Things | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Down Depressed or Hopeless | 14 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Down Depressed or Hopeless | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Down Depressed or Hopeless | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Down Depressed or Hopeless | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Falling or Staying Asleep | 14 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Falling or Staying Asleep | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Falling or Staying Asleep | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Falling or Staying Asleep | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Tired or Little Energy | 14 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Tired or Little Energy | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Tired or Little Energy | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Tired or Little Energy | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Poor Appetite or Overeating | 12 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Poor Appetite or Overeating | 1 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Poor Appetite or Overeating | 1 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Poor Appetite or Overeating | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Bad About Yourself | 14 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Bad About Yourself | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Bad About Yourself | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Bad About Yourself | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Concentrating on Things | 14 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Concentrating on Things | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Concentrating on Things | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Concentrating on Things | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Moving Slowly or Fidgety/Restless | 14 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Moving Slowly or Fidgety/Restless | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Moving Slowly or Fidgety/Restless | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Moving Slowly or Fidgety/Restless | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Thoughts You Be Better Off Dead | 14 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Thoughts You Be Better Off Dead | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Thoughts You Be Better Off Dead | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Thoughts You Be Better Off Dead | 0 | - |
| Follow Up Little Interest/Pleasure in Things | 15 | - |
| Follow Up Little Interest/Pleasure in Things | 0 | - |
| Follow Up Little Interest/Pleasure in Things | 0 | - |
| Follow Up Little Interest/Pleasure in Things | 0 | - |
| Follow Up Feeling Down Depressed or Hopeless | 15 | - |
| Follow Up Feeling Down Depressed or Hopeless | 0 | - |
| Follow Up Feeling Down Depressed or Hopeless | 0 | - |
| Follow Up Feeling Down Depressed or Hopeless | 0 | - |
| Follow Up Trouble Falling or Staying Asleep | 15 | - |
| Follow Up Trouble Falling or Staying Asleep | 0 | - |
| Follow Up Trouble Falling or Staying Asleep | 0 | - |
| Follow Up Trouble Falling or Staying Asleep | 0 | - |
| Follow Up Feeling Tired or Little Energy | 15 | - |
| Follow Up Feeling Tired or Little Energy | 0 | - |
| Follow Up Feeling Tired or Little Energy | 0 | - |
| Follow Up Feeling Tired or Little Energy | 0 | - |
| Follow Up Poor Appetite or Overeating | 15 | - |
| Follow Up Poor Appetite or Overeating | 0 | - |
| Follow Up Poor Appetite or Overeating | 0 | - |
| Follow Up Poor Appetite or Overeating | 0 | - |
| Follow Up Feeling Bad About Yourself | 15 | - |
| Follow Up Feeling Bad About Yourself | 0 | - |
| Follow Up Feeling Bad About Yourself | 0 | - |
| Follow Up Feeling Bad About Yourself | 0 | - |
| Follow Up Trouble Concentrating on Things | 15 | - |
| Follow Up Trouble Concentrating on Things | 0 | - |
| Follow Up Trouble Concentrating on Things | 0 | - |
| Follow Up Trouble Concentrating on Things | 0 | - |
| Follow Up Moving Slowly or Fidgety/Restless | 15 | - |
| Follow Up Moving Slowly or Fidgety/Restless | 0 | - |
| Follow Up Moving Slowly or Fidgety/Restless | 0 | - |
| Follow Up Moving Slowly or Fidgety/Restless | 0 | - |
| Follow Up Thoughts You Be Better Off Dead | 15 | - |
| Follow Up Thoughts You Be Better Off Dead | 0 | - |
| Follow Up Thoughts You Be Better Off Dead | 0 | - |
| Follow Up Thoughts You Be Better Off Dead | 0 | - |
| ET Little Interest/Pleasure in Things | 1 | - |
| ET Little Interest/Pleasure in Things | 0 | - |
| ET Little Interest/Pleasure in Things | 0 | - |
| ET Little Interest/Pleasure in Things | 0 | - |
| ET Feeling Down Depressed or Hopeless | 1 | - |
| ET Feeling Down Depressed or Hopeless | 0 | - |
| ET Feeling Down Depressed or Hopeless | 0 | - |
| ET Feeling Down Depressed or Hopeless | 0 | - |
| ET Trouble Falling or Staying Asleep | 1 | - |
| ET Trouble Falling or Staying Asleep | 0 | - |
| ET Trouble Falling or Staying Asleep | 0 | - |
| ET Trouble Falling or Staying Asleep | 0 | - |
| ET Feeling Tired or Little Energy | 1 | - |
| ET Feeling Tired or Little Energy | 0 | - |
| ET Feeling Tired or Little Energy | 0 | - |
| ET Feeling Tired or Little Energy | 0 | - |
| ET Poor Appetite or Overeating | 1 | - |
| ET Poor Appetite or Overeating | 0 | - |
| ET Poor Appetite or Overeating | 0 | - |
| ET Poor Appetite or Overeating | 0 | - |
| ET Feeling Bad About Yourself | 1 | - |
| ET Feeling Bad About Yourself | 0 | - |
| ET Feeling Bad About Yourself | 0 | - |
| ET Feeling Bad About Yourself | 0 | - |
| ET Trouble Concentrating on Things | 1 | - |
| ET Trouble Concentrating on Things | 0 | - |
| ET Trouble Concentrating on Things | 0 | - |
| ET Trouble Concentrating on Things | 0 | - |
| ET Moving Slowly or Fidgety/Restless | 1 | - |
| ET Moving Slowly or Fidgety/Restless | 0 | - |
| ET Moving Slowly or Fidgety/Restless | 0 | - |
| ET Moving Slowly or Fidgety/Restless | 0 | - |
| ET Thoughts You Be Better Off Dead | 1 | - |
| ET Thoughts You Be Better Off Dead | 0 | - |
| ET Thoughts You Be Better Off Dead | 0 | - |
| ET Thoughts You Be Better Off Dead | 0 | - |
Secondary/protocol endpoint
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Time frame:At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15, and 22, Period 4 Day 1, Period 6 Days 1, 9, and 16, Period 8 Day 2, at Follow Up visit (Days 68-71) and Early Termination
threshold achievement, improvement
Safety / tolerability / PK
14 endpointsPrimary/registry result
Area Under the Plasma Concentration-time Profile From Time 0 to Last Quantifiable Concentration (AUClast) of Rosuvastatin in Periods 1, 4 and 7
Time frame:At 0 (prior to rosuvastatin dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, and 72 hours post rosuvastatin dose on Day 1 in Periods 1, 4, and 7
concentration, descriptive
Posted result
| Group | Geometric mean · nanogram*hour per milliliter (ng*hr/mL) | 95% CI |
|---|---|---|
| Rosuvastatin 10mg (Period 1) | 35.17 | - |
| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4) | 72.15 | - |
| PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7) | 100.90 | - |
Adjusted geometric mean ratio (%)202.9490% CI167.14 - 246.41Mixed Models Analysis
Comparison for AUClast (PF-06882961 120mg BID + rosuvastatin 10mg \[Period 4\] vs Rosuvastatin 10mg \[Period 1\])
Adjusted geometric mean ratio (%)283.7390% CI233.68 - 344.51Mixed Models Analysis
Comparison for AUClast (PF-06882961 200mg BID + rosuvastatin 10mg \[Period 7\] vs Rosuvastatin 10mg \[Period 1\])
Primary/registry result
AUClast of Midazolam in Periods 2, 5 and 8
Time frame:At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post midazolam dose on Day 1 in Periods 2, 5, and 8
descriptive
Posted result
| Group | Geometric mean · nanogram*hour per milliliter (ng*hr/mL) | 95% CI |
|---|---|---|
| Midazolam 2mg (Period 2) | 39.24 | - |
| PF-06882961 120mg BID + Midazolam 2mg (Period 5) | 19.98 | - |
| PF-06882961 200mg BID + Midazolam 2mg (Period 8) | 20.21 | - |
Adjusted geometric mean ratio (%)50.5790% CI42.27 - 60.50Mixed Models Analysis
Comparison for AUClast (PF-06882961 120mg BID + midazolam 2mg \[Period 5\] vs Midazolam 2mg \[Period 2\])
Adjusted geometric mean ratio (%)50.5690% CI42.06 - 60.78Mixed Models Analysis
Comparison for AUClast (PF-06882961 200mg BID + midazolam 2mg \[Period 8\] vs Midazolam 2mg \[Period 2\])
Primary/protocol endpoint
Area Under the Plasma Concentration-time Profile From Time 0 to Last Quantifiable Concentration (AUClast) of Rosuvastatin in Periods 1, 4 and 7
Time frame:At 0 (prior to rosuvastatin dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, and 72 hours post rosuvastatin dose on Day 1 in Periods 1, 4, and 7
concentration, descriptive
Primary/protocol endpoint
AUClast of Midazolam in Periods 2, 5 and 8
Time frame:At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post midazolam dose on Day 1 in Periods 2, 5, and 8
concentration, descriptive
Secondary/registry result
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame:From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Rosuvastatin 10mg (Period 1)All-causality TEAEs | 0 | - |
| Treatment-related TEAEs | 0 | - |
| Midazolam 2mg (Period 2)All-causality TEAEs | 2 | - |
| Treatment-related TEAEs | 0 | - |
| PF-06882961 Titration up to 120mg BID (Period 3)All-causality TEAEs | 13 | - |
| Treatment-related TEAEs | 11 | - |
| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)All-causality TEAEs | 6 | - |
| Treatment-related TEAEs | 5 | - |
| PF-06882961 120mg BID + Midazolam 2mg (Period 5)All-causality TEAEs | 5 | - |
| Treatment-related TEAEs | 5 | - |
| PF-06882961 Titration up to 200mg BID (Period 6)All-causality TEAEs | 11 | - |
| Treatment-related TEAEs | 10 | - |
| PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)All-causality TEAEs | 7 | - |
| Treatment-related TEAEs | 3 | - |
| PF-06882961 200mg BID + Midazolam 2mg (Period 8)All-causality TEAEs | 8 | - |
| Treatment-related TEAEs | 7 | - |
Secondary/registry result
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)
Time frame:From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Rosuvastatin 10mg (Period 1) | 0 | - |
| Midazolam 2mg (Period 2) | 3 | - |
| PF-06882961 Titration up to 120mg BID (Period 3) | 5 | - |
| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4) | 2 | - |
| PF-06882961 120mg BID + Midazolam 2mg (Period 5) | 3 | - |
| PF-06882961 Titration up to 200mg BID (Period 6) | 5 | - |
| PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7) | 0 | - |
| PF-06882961 200mg BID + Midazolam 2mg (Period 8) | 9 | - |
Secondary/registry result
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Time frame:From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Rosuvastatin 10mg (Period 1)Pulse rate value <40bpm | 0 | - |
| Pulse rate value >120bpm | 0 | - |
| Supine diastolic BP value <50mmHg | 0 | - |
| Supine diastolic BP change >=20mmHg increase | 0 | - |
| Supine diastolic BP change >=20mmHg decrease | 0 | - |
| Supine systolic BP value <90mmHg | 0 | - |
| Supine systolic BP change >=30mmHg increase | 0 | - |
| Supine systolic BP change >=30mmHg decrease | 0 | - |
| Midazolam 2mg (Period 2)Pulse rate value <40bpm | 0 | - |
| Pulse rate value >120bpm | 0 | - |
| Supine diastolic BP value <50mmHg | 0 | - |
| Supine diastolic BP change >=20mmHg increase | 0 | - |
| Supine diastolic BP change >=20mmHg decrease | 0 | - |
| Supine systolic BP value <90mmHg | 0 | - |
| Supine systolic BP change >=30mmHg increase | 0 | - |
| Supine systolic BP change >=30mmHg decrease | 0 | - |
| PF-06882961 Titration up to 120mg BID (Period 3)Pulse rate value <40bpm | 0 | - |
| Pulse rate value >120bpm | 0 | - |
| Supine diastolic BP value <50mmHg | 0 | - |
| Supine diastolic BP change >=20mmHg increase | 0 | - |
| Supine diastolic BP change >=20mmHg decrease | 1 | - |
| Supine systolic BP value <90mmHg | 0 | - |
| Supine systolic BP change >=30mmHg increase | 0 | - |
| Supine systolic BP change >=30mmHg decrease | 2 | - |
| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)Pulse rate value <40bpm | 0 | - |
| Pulse rate value >120bpm | 0 | - |
| Supine diastolic BP value <50mmHg | 0 | - |
| Supine diastolic BP change >=20mmHg increase | 0 | - |
| Supine diastolic BP change >=20mmHg decrease | 0 | - |
| Supine systolic BP value <90mmHg | 1 | - |
| Supine systolic BP change >=30mmHg increase | 0 | - |
| Supine systolic BP change >=30mmHg decrease | 0 | - |
| PF-06882961 120mg BID + Midazolam 2mg (Period 5)Pulse rate value <40bpm | 0 | - |
| Pulse rate value >120bpm | 0 | - |
| Supine diastolic BP value <50mmHg | 0 | - |
| Supine diastolic BP change >=20mmHg increase | 0 | - |
| Supine diastolic BP change >=20mmHg decrease | 3 | - |
| Supine systolic BP value <90mmHg | 0 | - |
| Supine systolic BP change >=30mmHg increase | 0 | - |
| Supine systolic BP change >=30mmHg decrease | 2 | - |
| PF-06882961 Titration up to 200mg BID (Period 6)Pulse rate value <40bpm | 0 | - |
| Pulse rate value >120bpm | 0 | - |
| Supine diastolic BP value <50mmHg | 0 | - |
| Supine diastolic BP change >=20mmHg increase | 0 | - |
| Supine diastolic BP change >=20mmHg decrease | 3 | - |
| Supine systolic BP value <90mmHg | 1 | - |
| Supine systolic BP change >=30mmHg increase | 0 | - |
| Supine systolic BP change >=30mmHg decrease | 3 | - |
| PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)Pulse rate value <40bpm | 0 | - |
| Pulse rate value >120bpm | 1 | - |
| Supine diastolic BP value <50mmHg | 0 | - |
| Supine diastolic BP change >=20mmHg increase | 0 | - |
| Supine diastolic BP change >=20mmHg decrease | 1 | - |
| Supine systolic BP value <90mmHg | 0 | - |
| Supine systolic BP change >=30mmHg increase | 0 | - |
| Supine systolic BP change >=30mmHg decrease | 2 | - |
| PF-06882961 200mg BID + Midazolam 2mg (Period 8)Pulse rate value <40bpm | 0 | - |
| Pulse rate value >120bpm | 0 | - |
| Supine diastolic BP value <50mmHg | 1 | - |
| Supine diastolic BP change >=20mmHg increase | 0 | - |
| Supine diastolic BP change >=20mmHg decrease | 1 | - |
| Supine systolic BP value <90mmHg | 0 | - |
| Supine systolic BP change >=30mmHg increase | 0 | - |
| Supine systolic BP change >=30mmHg decrease | 0 | - |
Secondary/registry result
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
Time frame:From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Rosuvastatin 10mg (Period 1)PR interval value>=300 msec | 0 | - |
| PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase) | 0 | - |
| QRS interval value>=140 msec | 0 | - |
| QRS interval %change >=50% | 0 | - |
| QTcF value >450 and <=480 msec | 0 | - |
| QTcF value >480 and <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF change >30 and <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| Midazolam 2mg (Period 2)PR interval value>=300 msec | 0 | - |
| PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase) | 0 | - |
| QRS interval value>=140 msec | 0 | - |
| QRS interval %change >=50% | 0 | - |
| QTcF value >450 and <=480 msec | 1 | - |
| QTcF value >480 and <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF change >30 and <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 Titration up to 120mg BID (Period 3)PR interval value>=300 msec | 0 | - |
| PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase) | 0 | - |
| QRS interval value>=140 msec | 0 | - |
| QRS interval %change >=50% | 0 | - |
| QTcF value >450 and <=480 msec | 2 | - |
| QTcF value >480 and <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF change >30 and <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)PR interval value>=300 msec | 1 | - |
| PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase) | 1 | - |
| QRS interval value>=140 msec | 0 | - |
| QRS interval %change >=50% | 0 | - |
| QTcF value >450 and <=480 msec | 0 | - |
| QTcF value >480 and <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF change >30 and <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 120mg BID + Midazolam 2mg (Period 5)PR interval value>=300 msec | 1 | - |
| PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase) | 1 | - |
| QRS interval value>=140 msec | 0 | - |
| QRS interval %change >=50% | 0 | - |
| QTcF value >450 and <=480 msec | 0 | - |
| QTcF value >480 and <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF change >30 and <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 Titration up to 200mg BID (Period 6)PR interval value>=300 msec | 0 | - |
| PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase) | 0 | - |
| QRS interval value>=140 msec | 0 | - |
| QRS interval %change >=50% | 0 | - |
| QTcF value >450 and <=480 msec | 1 | - |
| QTcF value >480 and <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF change >30 and <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)PR interval value>=300 msec | 0 | - |
| PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase) | 1 | - |
| QRS interval value>=140 msec | 0 | - |
| QRS interval %change >=50% | 0 | - |
| QTcF value >450 and <=480 msec | 0 | - |
| QTcF value >480 and <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF change >30 and <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
| PF-06882961 200mg BID + Midazolam 2mg (Period 8)PR interval value>=300 msec | 0 | - |
| PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase) | 0 | - |
| QRS interval value>=140 msec | 0 | - |
| QRS interval %change >=50% | 0 | - |
| QTcF value >450 and <=480 msec | 0 | - |
| QTcF value >480 and <=500 msec | 0 | - |
| QTcF value >500 msec | 0 | - |
| QTcF change >30 and <=60 msec | 0 | - |
| QTcF change >60 msec | 0 | - |
Secondary/registry result
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame:At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15, and 22, Period 4 Day 1, Period 6 Days 1, 9, and 16, Period 8 Day 2, at Follow Up visit (Days 68-71) and Early Termination
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| All ParticipantsBL | 0 | - |
| BL (Past 12 months) | 0 | - |
| Period 3 Day 1 / PF-06882961 titration up to 120mg BID (Since last visit) | 0 | - |
| Period 3 Day 8 / PF-06882961 titration up to 120mg BID (Since last visit) | 0 | - |
| Period 3 Day 15 / PF-06882961 titration up to 120mg BID (Since last visit) | 0 | - |
| Period 3 Day 22 / PF-06882961 titration up to 120mg BID (Since last visit) | 0 | - |
| Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg (Since last visit) | 0 | - |
| Period 6 Day 1 / PF-06882961 titration up to 200mg BID (Since last visit) | 0 | - |
| Period 6 Day 9 / PF-06882961 titration up to 200mg BID (Since last visit) | 0 | - |
| Period 6 Day 16 / PF-06882961 titration up to 200mg BID (Since last visit) | 0 | - |
| Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg (Since last visit) | 0 | - |
| Follow Up (Since last visit) | 0 | - |
| Early Termination (ET) (Since last visit) | 0 | - |
Secondary/protocol endpoint
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame:From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
Treatment-emergent AEs (any)
event count, event
Secondary/protocol endpoint
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)
Time frame:From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)
descriptive
Secondary/protocol endpoint
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Time frame:From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)
threshold achievement, event
componentsSystolic BP, change, Diastolic BP, change, Heart rate, change
Secondary/protocol endpoint
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
Time frame:From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)
threshold achievement, event
Secondary/protocol endpoint
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame:At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15, and 22, Period 4 Day 1, Period 6 Days 1, 9, and 16, Period 8 Day 2, at Follow Up visit (Days 68-71) and Early Termination
threshold achievement, event
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.