← Trials/Trial dossier/NCT05788328
A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants
A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF PF-07081532 ADMINISTRATION ON THE SINGLE-DOSE PHARMACOKINETICS OF DABIGATRAN AND ROSUVASTATIN IN OVERWEIGHT OR OBESE ADULT PARTICIPANTS
Lead sponsor
Asset
Lotiglipron
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
16
actual
Study population
Healthy volunteers, Obesity / overweight
Key I/E criteria
•BMI ≥25•Healthy volunteers
Primary endpoints
•AUC From Time Zero (0) Extrapolated to Infinity (AUCinf) of Total Dabigatran•AUC From Time 0 to the Last Measurable Concentration (AUClast) of Total•AUCinf of Rosuvastatin in Period 2, 5 and 8
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Otherwise healthy female and male participants must be at least 18 years of age at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurement, standard 12-lead ECG and clinical laboratory tests)
2. BMI: ≥25.0 kg/m2 at Screening
3. Stable body weight, defined as <5 kg change (per participant report) for 90 days before Screening
Exclusion criteria
1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
2. Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at Screening
3. History of myocardial infarction, unstable angina, arterial revascularization, mechanical prosthetic heart valve, stroke, New York Association Functional Class II-IV heart failure, or transient ischemic attack within 6 months of Screening
4. Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin)
5. Personal or family history of MTC or MEN2, or study participants with suspected MTC per the investigator's judgment
6. Acute pancreatitis, a history of repeated episodes of acute pancreatitis, or history of chronic pancreatitis
7. Symptomatic gallbladder disease
8. Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders
9. History of depressive disorder or history of other severe psychiatric disorders within the last 2 years from Screening
10. Any lifetime history of a suicide attempt
11. Known medical history of active liver disease, or prior known drug-induced liver injury
12. History of HIV infection
13. Recent history of bleeding, or risks of bleeding, or abnormal coagulation test (INR >1.3) result at Screening
14. Use of prohibited medications
15. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest
16. Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study result
17. Participants with clinical laboratory test abnormalities at Screening
Endpoints (48)
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
Weight & body composition
2 endpointsPercent Change From Baseline in Body Weight
Time frame:Baseline, Day 1 and 8 of Period 3, Day 1 of Period 5, Day 5 and 12 of Period 6, Day 1 and 5 of Period 8 and follow-up (28-35 days post last dose; up to 76 to 83 days)
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percent change | 95% CI |
|---|---|---|
| All ParticipantsDay 1 of Period 3 | -0.51 | — |
| Day 8 of Period 3 | -1.02 | — |
| Day 1 of Period 5 | -2.58 | — |
| Day 5 of Period 6 | -3.32 | — |
| Day 12 of Period 6 | -4.82 | — |
| Day 1 of Period 8 | -6.52 | — |
| Day 5 of Period 8 | -6.90 | — |
| Follow-up | -6.01 | — |
Percent Change From Baseline in Body Weight
Time frame:Baseline, Day 1 and 8 of Period 3, Day 1 of Period 5, Day 5 and 12 of Period 6, Day 1 and 5 of Period 8 and follow-up (28-35 days post last dose; up to 76 to 83 days)
Body weight, % change
percent change from baseline, improvement
Patient-reported / QoL
2 endpointsNumber of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Time frame:Day 1 prior to treatment (Day -1) in Period 1; Day 8 of Period 3; Days 5 of Period 6; Day 1 and 5 of Period 8; Follow-up: up to 53 to 56 days post last dose of study intervention
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| All ParticipantsDay -1 of Period 1: Little interest/pleasure in things | 16 | — |
| Day -1 of Period 1: Little interest/pleasure in things | 0 | — |
| Day -1 of Period 1: Little interest/pleasure in things | 0 | — |
| Day -1 of Period 1: Little interest/pleasure in things | 0 | — |
| Day -1 of Period 1: Feeling down depressed or hopeless | 16 | — |
| Day -1 of Period 1: Feeling down depressed or hopeless | 0 | — |
| Day -1 of Period 1: Feeling down depressed or hopeless | 0 | — |
| Day -1 of Period 1: Feeling down depressed or hopeless | 0 | — |
| Day -1 of Period 1: Trouble falling or staying asleep | 15 | — |
| Day -1 of Period 1: Trouble falling or staying asleep | 1 | — |
| Day -1 of Period 1: Trouble falling or staying asleep | 0 | — |
| Day -1 of Period 1: Trouble falling or staying asleep | 0 | — |
| Day -1 of Period 1: Feeling tired or little energy | 16 | — |
| Day -1 of Period 1: Feeling tired or little energy | 0 | — |
| Day -1 of Period 1: Feeling tired or little energy | 0 | — |
| Day -1 of Period 1: Feeling tired or little energy | 0 | — |
| Day -1 of Period 1: Poor appetite or overeating | 16 | — |
| Day -1 of Period 1: Poor appetite or overeating | 0 | — |
| Day -1 of Period 1: Poor appetite or overeating | 0 | — |
| Day -1 of Period 1: Poor appetite or overeating | 0 | — |
| Day -1 of Period 1: Feeling bad about yourself | 16 | — |
| Day -1 of Period 1: Feeling bad about yourself | 0 | — |
| Day -1 of Period 1: Feeling bad about yourself | 0 | — |
| Day -1 of Period 1: Feeling bad about yourself | 0 | — |
| Day -1 of Period 1: Trouble concentrating on things | 15 | — |
| Day -1 of Period 1: Trouble concentrating on things | 1 | — |
| Day -1 of Period 1: Trouble concentrating on things | 0 | — |
| Day -1 of Period 1: Trouble concentrating on things | 0 | — |
| Day -1 of Period 1: Moving slowly or fidgety/restless | 16 | — |
| Day -1 of Period 1: Moving slowly or fidgety/restless | 0 | — |
| Day -1 of Period 1: Moving slowly or fidgety/restless | 0 | — |
| Day -1 of Period 1: Moving slowly or fidgety/restless | 0 | — |
| Day -1 of Period 1: Thoughts You be better off dead | 16 | — |
| Day -1 of Period 1: Thoughts You be better off dead | 0 | — |
| Day -1 of Period 1: Thoughts You be better off dead | 0 | — |
| Day -1 of Period 1: Thoughts You be better off dead | 0 | — |
| Day 8 of Period 3: Little interest/pleasure in things | 16 | — |
| Day 8 of Period 3: Little interest/pleasure in things | 0 | — |
| Day 8 of Period 3: Little interest/pleasure in things | 0 | — |
| Day 8 of Period 3: Little interest/pleasure in things | 0 | — |
| Day 8 of Period 3: Feeling down depressed or hopeless | 16 | — |
| Day 8 of Period 3: Feeling down depressed or hopeless | 0 | — |
| Day 8 of Period 3: Feeling down depressed or hopeless | 0 | — |
| Day 8 of Period 3: Feeling down depressed or hopeless | 0 | — |
| Day 8 of Period 3: Trouble falling or staying asleep | 15 | — |
| Day 8 of Period 3: Trouble falling or staying asleep | 1 | — |
| Day 8 of Period 3: Trouble falling or staying asleep | 0 | — |
| Day 8 of Period 3: Trouble falling or staying asleep | 0 | — |
| Day 8 of Period 3: Feeling tired or little energy | 16 | — |
| Day 8 of Period 3: Feeling tired or little energy | 0 | — |
| Day 8 of Period 3: Feeling tired or little energy | 0 | — |
| Day 8 of Period 3: Feeling tired or little energy | 0 | — |
| Day 8 of Period 3: Poor appetite or overeating | 15 | — |
| Day 8 of Period 3: Poor appetite or overeating | 1 | — |
| Day 8 of Period 3: Poor appetite or overeating | 0 | — |
| Day 8 of Period 3: Poor appetite or overeating | 0 | — |
| Day 8 of Period 3: Feeling bad about yourself | 16 | — |
| Day 8 of Period 3: Feeling bad about yourself | 0 | — |
| Day 8 of Period 3: Feeling bad about yourself | 0 | — |
| Day 8 of Period 3: Feeling bad about yourself | 0 | — |
| Day 8 of Period 3: Trouble concentrating on things | 15 | — |
| Day 8 of Period 3: Trouble concentrating on things | 1 | — |
| Day 8 of Period 3: Trouble concentrating on things | 0 | — |
| Day 8 of Period 3: Trouble concentrating on things | 0 | — |
| Day 8 of Period 3: Moving slowly or fidgety/restless | 16 | — |
| Day 8 of Period 3: Moving slowly or fidgety/restless | 0 | — |
| Day 8 of Period 3: Moving slowly or fidgety/restless | 0 | — |
| Day 8 of Period 3: Moving slowly or fidgety/restless | 0 | — |
| Day 8 of Period 3: Thoughts you be better off dead | 16 | — |
| Day 8 of Period 3: Thoughts you be better off dead | 0 | — |
| Day 8 of Period 3: Thoughts you be better off dead | 0 | — |
| Day 8 of Period 3: Thoughts you be better off dead | 0 | — |
| Day 5 of Period 6: Little interest/pleasure in things | 15 | — |
| Day 5 of Period 6: Little interest/pleasure in things | 0 | — |
| Day 5 of Period 6: Little interest/pleasure in things | 0 | — |
| Day 5 of Period 6: Little interest/pleasure in things | 0 | — |
| Day 5 of Period 6: Feeling down depressed or hopeless | 15 | — |
| Day 5 of Period 6: Feeling down depressed or hopeless | 0 | — |
| Day 5 of Period 6: Feeling down depressed or hopeless | 0 | — |
| Day 5 of Period 6: Feeling down depressed or hopeless | 0 | — |
| Day 5 of Period 6: Trouble falling or staying asleep | 14 | — |
| Day 5 of Period 6: Trouble falling or staying asleep | 1 | — |
| Day 5 of Period 6: Trouble falling or staying asleep | 0 | — |
| Day 5 of Period 6: Trouble falling or staying asleep | 0 | — |
| Day 5 of Period 6: Feeling tired or little energy | 14 | — |
| Day 5 of Period 6: Feeling tired or little energy | 1 | — |
| Day 5 of Period 6: Feeling tired or little energy | 0 | — |
| Day 5 of Period 6: Feeling tired or little energy | 0 | — |
| Day 5 of Period 6: Poor appetite or overeating | 8 | — |
| Day 5 of Period 6: Poor appetite or overeating | 4 | — |
| Day 5 of Period 6: Poor appetite or overeating | 1 | — |
| Day 5 of Period 6: Poor appetite or overeating | 2 | — |
| Day 5 of Period 6: Feeling bad about yourself | 15 | — |
| Day 5 of Period 6: Feeling bad about yourself | 0 | — |
| Day 5 of Period 6: Feeling bad about yourself | 0 | — |
| Day 5 of Period 6: Feeling bad about yourself | 0 | — |
| Day 5 of Period 6: Trouble concentrating on things | 15 | — |
| Day 5 of Period 6: Trouble concentrating on things | 0 | — |
| Day 5 of Period 6: Trouble concentrating on things | 0 | — |
| Day 5 of Period 6: Trouble concentrating on things | 0 | — |
| Day 5 of Period 6: Moving slowly or fidgety/restless | 15 | — |
| Day 5 of Period 6: Moving slowly or fidgety/restless | 0 | — |
| Day 5 of Period 6: Moving slowly or fidgety/restless | 0 | — |
| Day 5 of Period 6: Moving slowly or fidgety/restless | 0 | — |
| Day 5 of Period 6: Thoughts you be better off dead | 15 | — |
| Day 5 of Period 6: Thoughts you be better off dead | 0 | — |
| Day 5 of Period 6: Thoughts you be better off dead | 0 | — |
| Day 5 of Period 6: Thoughts you be better off dead | 0 | — |
| Day 1 of Period 8: PHQ01- Little interest/pleasure in things | 14 | — |
| Day 1 of Period 8: PHQ01- Little interest/pleasure in things | 1 | — |
| Day 1 of Period 8: PHQ01- Little interest/pleasure in things | 0 | — |
| Day 1 of Period 8: PHQ01- Little interest/pleasure in things | 0 | — |
| Day 1 of Period 8: Feeling down depressed or hopeless | 15 | — |
| Day 1 of Period 8: Feeling down depressed or hopeless | 0 | — |
| Day 1 of Period 8: Feeling down depressed or hopeless | 0 | — |
| Day 1 of Period 8: Feeling down depressed or hopeless | 0 | — |
| Day 1 of Period 8: Trouble falling or staying asleep | 13 | — |
| Day 1 of Period 8: Trouble falling or staying asleep | 2 | — |
| Day 1 of Period 8: Trouble falling or staying asleep | 0 | — |
| Day 1 of Period 8: Trouble falling or staying asleep | 0 | — |
| Day 1 of Period 8: Feeling tired or little energy | 11 | — |
| Day 1 of Period 8: Feeling tired or little energy | 3 | — |
| Day 1 of Period 8: Feeling tired or little energy | 0 | — |
| Day 1 of Period 8: Feeling tired or little energy | 1 | — |
| Day 1 of Period 8: Poor appetite or overeating | 5 | — |
| Day 1 of Period 8: Poor appetite or overeating | 5 | — |
| Day 1 of Period 8: Poor appetite or overeating | 1 | — |
| Day 1 of Period 8: Poor appetite or overeating | 4 | — |
| Day 1 of Period 8: Feeling bad about yourself | 15 | — |
| Day 1 of Period 8: Feeling bad about yourself | 0 | — |
| Day 1 of Period 8: Feeling bad about yourself | 0 | — |
| Day 1 of Period 8: Feeling bad about yourself | 0 | — |
| Day 1 of Period 8: Trouble concentrating on things | 14 | — |
| Day 1 of Period 8: Trouble concentrating on things | 1 | — |
| Day 1 of Period 8: Trouble concentrating on things | 0 | — |
| Day 1 of Period 8: Trouble concentrating on things | 0 | — |
| Day 1 of Period 8: Moving slowly or fidgety/restless | 14 | — |
| Day 1 of Period 8: Moving slowly or fidgety/restless | 1 | — |
| Day 1 of Period 8: Moving slowly or fidgety/restless | 0 | — |
| Day 1 of Period 8: Moving slowly or fidgety/restless | 0 | — |
| Day 1 of Period 8: Thoughts you be better off dead | 15 | — |
| Day 1 of Period 8: Thoughts you be better off dead | 0 | — |
| Day 1 of Period 8: Thoughts you be better off dead | 0 | — |
| Day 1 of Period 8: Thoughts you be better off dead | 0 | — |
| Day 5 of Period 8: Little interest/pleasure in things | 14 | — |
| Day 5 of Period 8: Little interest/pleasure in things | 1 | — |
| Day 5 of Period 8: Little interest/pleasure in things | 0 | — |
| Day 5 of Period 8: Little interest/pleasure in things | 0 | — |
| Day 5 of Period 8: Feeling down depressed or hopeless | 15 | — |
| Day 5 of Period 8: Feeling down depressed or hopeless | 0 | — |
| Day 5 of Period 8: Feeling down depressed or hopeless | 0 | — |
| Day 5 of Period 8: Feeling down depressed or hopeless | 0 | — |
| Day 5 of Period 8: Trouble falling or staying asleep | 13 | — |
| Day 5 of Period 8: Trouble falling or staying asleep | 2 | — |
| Day 5 of Period 8: Trouble falling or staying asleep | 0 | — |
| Day 5 of Period 8: Trouble falling or staying asleep | 0 | — |
| Day 5 of Period 8: Feeling tired or little energy | 10 | — |
| Day 5 of Period 8: Feeling tired or little energy | 3 | — |
| Day 5 of Period 8: Feeling tired or little energy | 0 | — |
| Day 5 of Period 8: Feeling tired or little energy | 2 | — |
| Day 5 of Period 8: Poor appetite or overeating | 6 | — |
| Day 5 of Period 8: Poor appetite or overeating | 6 | — |
| Day 5 of Period 8: Poor appetite or overeating | 0 | — |
| Day 5 of Period 8: Poor appetite or overeating | 3 | — |
| Day 5 of Period 8: Feeling bad about yourself | 15 | — |
| Day 5 of Period 8: Feeling bad about yourself | 0 | — |
| Day 5 of Period 8: Feeling bad about yourself | 0 | — |
| Day 5 of Period 8: Feeling bad about yourself | 0 | — |
| Day 5 of Period 8: Trouble concentrating on things | 14 | — |
| Day 5 of Period 8: Trouble concentrating on things | 1 | — |
| Day 5 of Period 8: Trouble concentrating on things | 0 | — |
| Day 5 of Period 8: Trouble concentrating on things | 0 | — |
| Day 5 of Period 8: Moving slowly or fidgety/restless | 14 | — |
| Day 5 of Period 8: Moving slowly or fidgety/restless | 1 | — |
| Day 5 of Period 8: Moving slowly or fidgety/restless | 0 | — |
| Day 5 of Period 8: Moving slowly or fidgety/restless | 0 | — |
| Day 5 of Period 8: Thoughts you be better off dead | 15 | — |
| Day 5 of Period 8: Thoughts you be better off dead | 0 | — |
| Day 5 of Period 8: Thoughts you be better off dead | 0 | — |
| Day 5 of Period 8: Thoughts you be better off dead | 0 | — |
| Follow-Up: Little interest/pleasure in things | 15 | — |
| Follow-Up: Little interest/pleasure in things | 1 | — |
| Follow-Up: Little interest/pleasure in things | 0 | — |
| Follow-Up: Little interest/pleasure in things | 0 | — |
| Follow-up: Feeling down depressed or hopeless | 16 | — |
| 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 | 1 | — |
| 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 | 1 | — |
| Follow-up: Feeling tired or little energy | 0 | — |
| Follow-up: Feeling tired or little energy | 0 | — |
| Follow-up: Poor appetite or overeating | 11 | — |
| Follow-up: Poor appetite or overeating | 3 | — |
| Follow-up: Poor appetite or overeating | 1 | — |
| Follow-up: Poor appetite or overeating | 1 | — |
| Follow-up: Feeling bad about yourself | 16 | — |
| 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 | 16 | — |
| 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 | 16 | — |
| 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 | 16 | — |
| 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 | — |
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Time frame:Day 1 prior to treatment (Day -1) in Period 1; Day 8 of Period 3; Days 5 of Period 6; Day 1 and 5 of Period 8; Follow-up: up to 53 to 56 days post last dose of study intervention
threshold achievement, improvement
Safety / tolerability / PK
44 endpointsArea Under the Concentration-Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanogram*hour/milliliter (ng*hr/mL) | 95% CI |
|---|---|---|
| Period 1: DE 150 mg | 1359 | — |
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 1195 | — |
| Period 7: PF-07081532 240 mg QD + DE 150 mg | 1141 | — |
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.
Area Under the Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
concentration, descriptive
Posted result
| Group | Value (geometric_mean), ng*hr/mL | 95% CI |
|---|---|---|
| Period 1: DE 150 mg | 1326 | — |
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 1154 | — |
| Period 7: PF-07081532 240 mg QD + DE 150 mg | 1089 | — |
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.
AUCinf of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
descriptive
Posted result
| Group | Value (geometric_mean), ng*hr/mL | 95% CI |
|---|---|---|
| Period 2: ROSU 10 mg | 26.86 | — |
| Period 5: ROSU 10mg + PF-07081532 80 mg QD | 67.79 | — |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 63.83 | — |
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.
AUClast of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
descriptive
Posted result
| Group | Value (geometric_mean), ng*hr/mL | 95% CI |
|---|---|---|
| Period 2: ROSU 10 mg | 29.69 | — |
| Period 5: ROSU 10mg + PF-07081532 80 mg QD | 63.30 | — |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 69.03 | — |
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.
Area Under the Concentration-Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
AUC₀–∞
concentration, descriptive
Area Under the Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
concentration, descriptive
AUCinf of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
AUC₀–∞
concentration, descriptive
AUClast of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
concentration, descriptive
Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities
Time frame:From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Period 1: DE 150 mg | 0 | — |
| Period 2: ROSU 10 mg | 0 | — |
| Period 3: PF-07081532 40 mg QD | 6 | — |
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 15 | — |
| Period 5: ROSU 10mg + PF-07081532 80 mg QD | 6 | — |
| Period 6: PF-07081532 240 mg QD | 15 | — |
| Period 7: PF-07081532 240 mg QD + DE 150 mg | 4 | — |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 9 | — |
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame:During treatment of the study (maximum up to 48 days)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Period 3: PF-07081532 40 mg QD | 2 | — |
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 1 | — |
| Period 5: ROSU 10mg + PF-07081532 80 mg QD | 1 | — |
| Period 6: PF-07081532 240 mg QD | 2 | — |
| Period 7: PF-07081532 240 mg QD + DE 150 mg | 3 | — |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 15 | — |
Number of Participants With Clinically Significant Vital Signs
Time frame:From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Period 1: DE 150 mg | 0 | — |
| Period 2: ROSU 10 mg | 0 | — |
| Period 3: PF-07081532 40 mg QD | 0 | — |
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 0 | — |
| Period 5: ROSU 10mg + PF-07081532 80 mg QD | 0 | — |
| Period 6: PF-07081532 240 mg QD | 0 | — |
| Period 7: PF-07081532 240 mg QD + DE 150 mg | 0 | — |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 0 | — |
Number of Participants With Pre-defined Criteria of Electrocardiogram (ECG) Parameters
Time frame:From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Period 1: DE 150 mg | 0 | — |
| Period 3: PF-07081532 40 mg QD | 0 | — |
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 0 | — |
| Period 6: PF-07081532 240 mg QD | 0 | — |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 0 | — |
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame:From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| All ParticipantsDay -1 of Period 1 (Completed suicide) | 0 | — |
| Day -1 of Period 1 (Suicide attempt) | 0 | — |
| Day -1 of Period 1 (Preparatory acts towards imminent suicidal behavior) | 0 | — |
| Day -1 of Period 1 (Suicidal ideation) | 0 | — |
| Day -1 of Period 1 (Self-injurious behavior, no suicidal intent) | 0 | — |
| Day 8 of Period 3 (Completed suicide) | 0 | — |
| Day 8 of Period 3 (Suicide attempt) | 0 | — |
| Day 8 of Period 3 (Preparatory acts towards imminent suicidal behavior) | 0 | — |
| Day 8 of Period 3 (Suicidal ideation) | 0 | — |
| Day 8 of Period 3 (Self-injurious behavior, no suicidal intent) | 0 | — |
| Day 5 of Period 6 (Completed suicide) | 0 | — |
| Day 5 of Period 6 (Suicide attempt) | 0 | — |
| Day 5 of Period 6 (Preparatory acts towards imminent suicidal behavior) | 0 | — |
| Day 5 of Period 6 (Suicidal ideation) | 0 | — |
| Day 5 of Period 6 (Self-injurious behavior, no suicidal intent) | 0 | — |
| Day 5 of Period 8 (Completed suicide) | 0 | — |
| Day 5 of Period 8 (Suicide attempt) | 0 | — |
| Day 5 of Period 8 (Preparatory acts towards imminent suicidal behavior) | 0 | — |
| Day 5 of Period 8 (Suicidal ideation) | 0 | — |
| Day 5 of Period 8 (Self-injurious behavior, no suicidal intent) | 0 | — |
| Follow-up (Completed suicide) | 0 | — |
| Follow-up (Suicide attempt) | 0 | — |
| Follow-up (Preparatory acts towards imminent suicidal behavior) | 0 | — |
| Follow-up (Suicidal ideation) | 0 | — |
| Follow-up (Self-injurious behavior, no suicidal intent) | 0 | — |
Maximum Observed Concentration (Cmax) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
concentration, descriptive
Posted result
| Group | Value (geometric_mean), ng/mL | 95% CI |
|---|---|---|
| Period 1: DE 150 mg | 186.0 | — |
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 86.01 | — |
| Period 7: PF-07081532 240 mg QD + DE 150 mg | 90.18 | — |
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.
Time for Cmax (Tmax) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
concentration, descriptive
Posted result
| Group | Value (median), Hours | 95% CI |
|---|---|---|
| Period 1: DE 150 mg | 3.00 | 2.00 – 4.00 |
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 6.00 | 2.00 – 12.0 |
| Period 7: PF-07081532 240 mg QD + DE 150 mg | 6.00 | 3.00 – 8.00 |
Terminal Half-Life (t1/2) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
concentration, descriptive
Posted result
| Group | Value (mean), Hours | 95% CI |
|---|---|---|
| Period 1: DE 150 mg | 8.921 | — |
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 9.023 | — |
| Period 7: PF-07081532 240 mg QD + DE 150 mg | 9.208 | — |
Apparent Volume of Distribution (Vz/F) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
descriptive
Posted result
| Group | Value (geometric_mean), Liters | 95% CI |
|---|---|---|
| Period 1: DE 150 mg | 1374 | — |
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 1618 | — |
| Period 7: PF-07081532 240 mg QD + DE 150 mg | 1707 | — |
Apparent Oral Clearance (CL/F) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
concentration, descriptive
Posted result
| Group | Value (geometric_mean), Liters/Hours | 95% CI |
|---|---|---|
| Period 1: DE 150 mg | 110.3 | — |
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 125.6 | — |
| Period 7: PF-07081532 240 mg QD + DE 150 mg | 131.5 | — |
Cmax of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
concentration, descriptive
Posted result
| Group | Value (geometric_mean), ng/mL | 95% CI |
|---|---|---|
| Period 2: ROSU 10 mg | 2.230 | — |
| Period 5: ROSU 10mg + PF-07081532 80 mg QD | 3.951 | — |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 4.964 | — |
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.
Tmax of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
concentration, descriptive
Posted result
| Group | Value (median), Hours | 95% CI |
|---|---|---|
| Period 2: ROSU 10 mg | 5.00 | 4.00 – 5.00 |
| Period 5: ROSU 10mg + PF-07081532 80 mg QD | 5.00 | 3.00 – 10.0 |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 5.00 | 3.00 – 6.00 |
t1/2 of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
concentration, descriptive
Posted result
| Group | Value (mean), Hours | 95% CI |
|---|---|---|
| Period 2: ROSU 10 mg | 25.40 | — |
| Period 5: ROSU 10mg + PF-07081532 80 mg QD | 25.52 | — |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 19.06 | — |
Vz/F of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
descriptive
Posted result
| Group | Value (geometric_mean), Liters | 95% CI |
|---|---|---|
| Period 2: ROSU 10 mg | 12900 | — |
| Period 5: ROSU 10mg + PF-07081532 80 mg QD | 4753 | — |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 4171 | — |
CL/F of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
descriptive
Posted result
| Group | Value (geometric_mean), Liters/Hours | 95% CI |
|---|---|---|
| Period 2: ROSU 10 mg | 372.5 | — |
| Period 5: ROSU 10mg + PF-07081532 80 mg QD | 147.4 | — |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 156.5 | — |
Area Under the Concentration-Time Curve From Time 0 to Time 24 Hours (AUC24) of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 14 and 24 hours post dose of PF-07081532 in Period 4 and 8
concentration, descriptive
Posted result
| Group | Value (geometric_mean), ng*hr/mL | 95% CI |
|---|---|---|
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 222000 | — |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 701300 | — |
Cmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 14 and 24 hours post dose of PF-07081532 in Period 4 and 8
concentration, descriptive
Posted result
| Group | Value (geometric_mean), ng/mL | 95% CI |
|---|---|---|
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 15600 | — |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 42730 | — |
Tmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 14 and 24 hours post dose of PF-07081532 in Period 4 and 8
concentration, descriptive
Posted result
| Group | Value (median), Hours | 95% CI |
|---|---|---|
| Period 4: DE 150 mg + PF-07081532 80 mg QD | 6.00 | 1.00 – 8.00 |
| Period 8: PF-07081532 240 mg QD + ROSU 10 mg | 4.00 | 2.00 – 10.0 |
Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities
Time frame:From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Treatment-emergent AEs (any)
event count, event
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame:During treatment of the study (maximum up to 48 days)
threshold achievement, event
Number of Participants With Clinically Significant Vital Signs
Time frame:From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
threshold achievement, event
Number of Participants With Pre-defined Criteria of Electrocardiogram (ECG) Parameters
Time frame:From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
threshold achievement, event
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame:From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
event count, event
Maximum Observed Concentration (Cmax) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
Cmax
concentration, descriptive
Time for Cmax (Tmax) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
Tmax
descriptive
Terminal Half-Life (t1/2) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
Half-life
descriptive
Apparent Volume of Distribution (Vz/F) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
descriptive
Apparent Oral Clearance (CL/F) of Total Dabigatran in Period 1, 4 and 7
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7
descriptive
Cmax of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
Cmax
concentration, descriptive
Tmax of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
Tmax
descriptive
t1/2 of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
Half-life
descriptive
Vz/F of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
descriptive
CL/F of Rosuvastatin in Period 2, 5 and 8
Time frame:Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8
descriptive
Area Under the Concentration-Time Curve From Time 0 to Time 24 Hours (AUC24) of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 14 and 24 hours post dose of PF-07081532 in Period 4 and 8
AUC₀–∞
concentration, descriptive
Cmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 14 and 24 hours post dose of PF-07081532 in Period 4 and 8
Cmax
concentration, descriptive
Tmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively
Time frame:Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 14 and 24 hours post dose of PF-07081532 in Period 4 and 8
Tmax
descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Journal of clinical pharmacology2026 May (month)PMID42053447doi:10.1002/jcph.70158via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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 1, 2026 snapshot.