← Trials/Trial dossier/NCT03538743
CompletedPhase 1Results posted
4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ESCALATING ORAL DOSES OF PF-06882961 IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS
Lead sponsor
Asset
Danuglipron
Oral · GLP-1 agonist
Listed sites
4
Recruiting sites
—
Enrollment
98
actual
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c 7-10.5%
Primary endpoints
•Treatment-emergent AEs (any)•Laboratory Abnormalities Without Regard•Abnormal Vital Signs
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
NCT IDNCT03538743
Org study IDC3421002
Timeline
Milestones
Study first posted2018-05-29actual
Study start2018-06-25actual
Primary completion2019-05-23actual
Study completion2019-06-10actual
Last update posted2020-07-01actual
Results first posted2020-07-01actual
Assets
Investigational agents
Study populations
Who this study enrolls
Type 2 diabetes
Eligibility
Who can enroll
Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Type 2 diabetes treated with a stable dose of metformin at least 500 mg
•HbA1c value between 7.0 and 10.5%
Exclusion criteria
- Type 1 diabetes or secondary forms of diabetes
Endpoints (11)
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.
Safety / tolerability / PK
11 endpointsPrimary/protocol endpoint
Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)
Time frame:From baseline to up to 35 days after last dose for a total of approximately 63 days
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboAll-causality AE | 17 | — |
| All-causality SAE | 0 | — |
| Treatment-related AE | 14 | — |
| Treatment-related SAE | 0 | — |
| PF-06882961 10mg BIDAll-causality AE | 6 | — |
| All-causality SAE | 0 | — |
| Treatment-related AE | 4 | — |
| Treatment-related SAE | 0 | — |
| PF-06882961 15mg BIDAll-causality AE | 8 | — |
| All-causality SAE | 0 | — |
| Treatment-related AE | 4 | — |
| Treatment-related SAE | 0 | — |
| PF-06882961 50mg BIDAll-causality AE | 10 | — |
| All-causality SAE | 0 | — |
| Treatment-related AE | 10 | — |
| Treatment-related SAE | 0 | — |
| PF-06882961 70mg BIDAll-causality AE | 8 | — |
| All-causality SAE | 0 | — |
| Treatment-related AE | 7 | — |
| Treatment-related SAE | 0 | — |
| PF-06882961 120mg BIDAll-causality AE | 8 | — |
| All-causality SAE | 0 | — |
| Treatment-related AE | 8 | — |
| Treatment-related SAE | 0 | — |
| PF-06882961 120mg BID STAll-causality AE | 9 | — |
| All-causality SAE | 1 | — |
| Treatment-related AE | 9 | — |
| Treatment-related SAE | 0 | — |
| PF-06882961 120mg QDAll-causality AE | 8 | — |
| All-causality SAE | 0 | — |
| Treatment-related AE | 8 | — |
| Treatment-related SAE | 0 | — |
| PF-06882961 200mg QD CRAll-causality AE | 9 | — |
| All-causality SAE | 0 | — |
| Treatment-related AE | 9 | — |
| Treatment-related SAE | 0 | — |
Primary/protocol endpoint
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
Time frame:From baseline to up to 14 days after last dose for a total of approximately 42 days
descriptive, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo | 24 | — |
| PF-06882961 10mg BID | 7 | — |
| PF-06882961 15mg BID | 8 | — |
| PF-06882961 50mg BID | 10 | — |
| PF-06882961 70mg BID | 8 | — |
| PF-06882961 120mg BID | 8 | — |
| PF-06882961 120mg BID ST | 9 | — |
| PF-06882961 120mg QD | 7 | — |
| PF-06882961 200mg QD CR | 10 | — |
Primary/protocol endpoint
Number of Participants With Abnormal Vital Signs
Time frame:From baseline to up to 14 days after last dose for a total of approximately 42 days
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboSupine SBP <90 mmHg | 3 | — |
| Supine SBP increase >=30 mmHg | 4 | — |
| Supine SBP decrease >=30 mmHg | 9 | — |
| Supine DBP <50 mmHg | 1 | — |
| Supine DBP increase >=20 mmHg | 1 | — |
| Supine DBP decrease >=20 mmHg | 6 | — |
| Supine pulse rate <40 bpm | 0 | — |
| Supine pulse rate >120 bpm | 0 | — |
| PF-06882961 10mg BIDSupine SBP <90 mmHg | 3 | — |
| Supine SBP increase >=30 mmHg | 0 | — |
| Supine SBP decrease >=30 mmHg | 2 | — |
| Supine DBP <50 mmHg | 1 | — |
| Supine DBP increase >=20 mmHg | 1 | — |
| Supine DBP decrease >=20 mmHg | 2 | — |
| Supine pulse rate <40 bpm | 0 | — |
| Supine pulse rate >120 bpm | 0 | — |
| PF-06882961 15mg BIDSupine SBP <90 mmHg | 2 | — |
| Supine SBP increase >=30 mmHg | 0 | — |
| Supine SBP decrease >=30 mmHg | 5 | — |
| Supine DBP <50 mmHg | 2 | — |
| Supine DBP increase >=20 mmHg | 1 | — |
| Supine DBP decrease >=20 mmHg | 1 | — |
| Supine pulse rate <40 bpm | 0 | — |
| Supine pulse rate >120 bpm | 0 | — |
| PF-06882961 50mg BIDSupine SBP <90 mmHg | 1 | — |
| Supine SBP increase >=30 mmHg | 2 | — |
| Supine SBP decrease >=30 mmHg | 3 | — |
| Supine DBP <50 mmHg | 1 | — |
| Supine DBP increase >=20 mmHg | 0 | — |
| Supine DBP decrease >=20 mmHg | 2 | — |
| Supine pulse rate <40 bpm | 0 | — |
| Supine pulse rate >120 bpm | 0 | — |
| PF-06882961 70mg BIDSupine SBP <90 mmHg | 3 | — |
| Supine SBP increase >=30 mmHg | 3 | — |
| Supine SBP decrease >=30 mmHg | 5 | — |
| Supine DBP <50 mmHg | 1 | — |
| Supine DBP increase >=20 mmHg | 4 | — |
| Supine DBP decrease >=20 mmHg | 1 | — |
| Supine pulse rate <40 bpm | 0 | — |
| Supine pulse rate >120 bpm | 0 | — |
| PF-06882961 120mg BIDSupine SBP <90 mmHg | 0 | — |
| Supine SBP increase >=30 mmHg | 1 | — |
| Supine SBP decrease >=30 mmHg | 3 | — |
| Supine DBP <50 mmHg | 0 | — |
| Supine DBP increase >=20 mmHg | 1 | — |
| Supine DBP decrease >=20 mmHg | 3 | — |
| Supine pulse rate <40 bpm | 0 | — |
| Supine pulse rate >120 bpm | 0 | — |
| PF-06882961 120mg BID STSupine SBP <90 mmHg | 3 | — |
| Supine SBP increase >=30 mmHg | 2 | — |
| Supine SBP decrease >=30 mmHg | 3 | — |
| Supine DBP <50 mmHg | 2 | — |
| Supine DBP increase >=20 mmHg | 2 | — |
| Supine DBP decrease >=20 mmHg | 4 | — |
| Supine pulse rate <40 bpm | 0 | — |
| Supine pulse rate >120 bpm | 0 | — |
| PF-06882961 120mg QDSupine SBP <90 mmHg | 0 | — |
| Supine SBP increase >=30 mmHg | 2 | — |
| Supine SBP decrease >=30 mmHg | 5 | — |
| Supine DBP <50 mmHg | 0 | — |
| Supine DBP increase >=20 mmHg | 2 | — |
| Supine DBP decrease >=20 mmHg | 2 | — |
| Supine pulse rate <40 bpm | 0 | — |
| Supine pulse rate >120 bpm | 0 | — |
| PF-06882961 200mg QD CRSupine SBP <90 mmHg | 1 | — |
| Supine SBP increase >=30 mmHg | 1 | — |
| Supine SBP decrease >=30 mmHg | 4 | — |
| Supine DBP <50 mmHg | 0 | — |
| Supine DBP increase >=20 mmHg | 1 | — |
| Supine DBP decrease >=20 mmHg | 3 | — |
| Supine pulse rate <40 bpm | 0 | — |
| Supine pulse rate >120 bpm | 0 | — |
Primary/protocol endpoint
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
Time frame:From baseline to up to 14 days after last dose for a total of approximately 42 days
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboPR interval ≥300 msec | 0 | — |
| %Change in PR interval ≥25/50% | 0 | — |
| QRS duration ≥140 msec | 0 | — |
| %Change in QRS duration ≥50% | 0 | — |
| QTcF interval >450 and ≤480 msec | 2 | — |
| QTcF interval >480 and ≤500 msec | 0 | — |
| QTcF interval >500 msec | 0 | — |
| Change in QTcF interval >30 and ≤60 msec | 0 | — |
| Change in QTcF interval >60 msec | 0 | — |
| PF-06882961 10mg BIDPR interval ≥300 msec | 0 | — |
| %Change in PR interval ≥25/50% | 0 | — |
| QRS duration ≥140 msec | 0 | — |
| %Change in QRS duration ≥50% | 0 | — |
| QTcF interval >450 and ≤480 msec | 0 | — |
| QTcF interval >480 and ≤500 msec | 0 | — |
| QTcF interval >500 msec | 0 | — |
| Change in QTcF interval >30 and ≤60 msec | 1 | — |
| Change in QTcF interval >60 msec | 0 | — |
| PF-06882961 15mg BIDPR interval ≥300 msec | 0 | — |
| %Change in PR interval ≥25/50% | 0 | — |
| QRS duration ≥140 msec | 0 | — |
| %Change in QRS duration ≥50% | 0 | — |
| QTcF interval >450 and ≤480 msec | 1 | — |
| QTcF interval >480 and ≤500 msec | 0 | — |
| QTcF interval >500 msec | 0 | — |
| Change in QTcF interval >30 and ≤60 msec | 0 | — |
| Change in QTcF interval >60 msec | 0 | — |
| PF-06882961 50mg BIDPR interval ≥300 msec | 0 | — |
| %Change in PR interval ≥25/50% | 0 | — |
| QRS duration ≥140 msec | 0 | — |
| %Change in QRS duration ≥50% | 0 | — |
| QTcF interval >450 and ≤480 msec | 0 | — |
| QTcF interval >480 and ≤500 msec | 0 | — |
| QTcF interval >500 msec | 0 | — |
| Change in QTcF interval >30 and ≤60 msec | 0 | — |
| Change in QTcF interval >60 msec | 0 | — |
| PF-06882961 70mg BIDPR interval ≥300 msec | 0 | — |
| %Change in PR interval ≥25/50% | 0 | — |
| QRS duration ≥140 msec | 0 | — |
| %Change in QRS duration ≥50% | 0 | — |
| QTcF interval >450 and ≤480 msec | 0 | — |
| QTcF interval >480 and ≤500 msec | 0 | — |
| QTcF interval >500 msec | 0 | — |
| Change in QTcF interval >30 and ≤60 msec | 0 | — |
| Change in QTcF interval >60 msec | 0 | — |
| PF-06882961 120mg BIDPR interval ≥300 msec | 0 | — |
| %Change in PR interval ≥25/50% | 0 | — |
| QRS duration ≥140 msec | 0 | — |
| %Change in QRS duration ≥50% | 0 | — |
| QTcF interval >450 and ≤480 msec | 0 | — |
| QTcF interval >480 and ≤500 msec | 0 | — |
| QTcF interval >500 msec | 0 | — |
| Change in QTcF interval >30 and ≤60 msec | 1 | — |
| Change in QTcF interval >60 msec | 0 | — |
| PF-06882961 120mg BID STPR interval ≥300 msec | 0 | — |
| %Change in PR interval ≥25/50% | 0 | — |
| QRS duration ≥140 msec | 0 | — |
| %Change in QRS duration ≥50% | 0 | — |
| QTcF interval >450 and ≤480 msec | 0 | — |
| QTcF interval >480 and ≤500 msec | 0 | — |
| QTcF interval >500 msec | 0 | — |
| Change in QTcF interval >30 and ≤60 msec | 0 | — |
| Change in QTcF interval >60 msec | 0 | — |
| PF-06882961 120mg QDPR interval ≥300 msec | 0 | — |
| %Change in PR interval ≥25/50% | 0 | — |
| QRS duration ≥140 msec | 0 | — |
| %Change in QRS duration ≥50% | 0 | — |
| QTcF interval >450 and ≤480 msec | 0 | — |
| QTcF interval >480 and ≤500 msec | 0 | — |
| QTcF interval >500 msec | 0 | — |
| Change in QTcF interval >30 and ≤60 msec | 0 | — |
| Change in QTcF interval >60 msec | 0 | — |
| PF-06882961 200mg QD CRPR interval ≥300 msec | 0 | — |
| %Change in PR interval ≥25/50% | 0 | — |
| QRS duration ≥140 msec | 0 | — |
| %Change in QRS duration ≥50% | 0 | — |
| QTcF interval >450 and ≤480 msec | 0 | — |
| QTcF interval >480 and ≤500 msec | 0 | — |
| QTcF interval >500 msec | 0 | — |
| Change in QTcF interval >30 and ≤60 msec | 0 | — |
| Change in QTcF interval >60 msec | 0 | — |
Secondary/protocol endpoint
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Time frame:0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanogram.hours/milliliter (ng.h/mL) | 95% CI |
|---|---|---|
| PF-06882961 15mg BID (Cohort 1)AUC24 on Day 1 | 707.5 | — |
| AUCtau1 on Day 1 | 288.1 | — |
| AUCtau2 on Day 1 | 414.8 | — |
| AUC24 on Day 14 or 21 | 853.8 | — |
| AUCtau1 on Day 14 or 21 | 348.6 | — |
| AUCtau2 on Day 14 or 21 | 500.1 | — |
| AUC24 on Day 28 | 876.7 | — |
| AUCtau1 on Day 28 | 331.1 | — |
| AUCtau2 on Day 28 | 534.7 | — |
| PF-06882961 50mg BID (Cohort 2)AUC24 on Day 1 | 1502 | — |
| AUCtau1 on Day 1 | 741.4 | — |
| AUCtau2 on Day 1 | 678.5 | — |
| AUC24 on Day 14 or 21 | 2092 | — |
| AUCtau1 on Day 14 or 21 | 880.3 | — |
| AUCtau2 on Day 14 or 21 | 1175 | — |
| AUC24 on Day 28 | 1653 | — |
| AUCtau1 on Day 28 | 671.1 | — |
| AUCtau2 on Day 28 | 960.1 | — |
| PF-06882961 70mg BID (Cohort 3)AUC24 on Day 1 | 645.8 | — |
| AUCtau1 on Day 1 | 279.7 | — |
| AUCtau2 on Day 1 | 364.9 | — |
| AUC24 on Day 14 or 21 | 2988 | — |
| AUCtau1 on Day 14 or 21 | 1462 | — |
| AUCtau2 on Day 14 or 21 | 1517 | — |
| AUC24 on Day 28 | 3171 | — |
| AUCtau1 on Day 28 | 1153 | — |
| AUCtau2 on Day 28 | 1970 | — |
| PF-06882961 120mg BID (Cohort 4)AUC24 on Day 1 | 666.1 | — |
| AUCtau1 on Day 1 | 260.3 | — |
| AUCtau2 on Day 1 | 401.9 | — |
| AUC24 on Day 14 or 21 | 8149 | — |
| AUCtau1 on Day 14 or 21 | 3772 | — |
| AUCtau2 on Day 14 or 21 | 4361 | — |
| AUC24 on Day 28 | 8368 | — |
| AUCtau1 on Day 28 | 3534 | — |
| AUCtau2 on Day 28 | 4852 | — |
| PF-06882961 10mg BID (Cohort 5)AUC24 on Day 1 | 178.7 | — |
| AUCtau1 on Day 1 | 74.50 | — |
| AUCtau2 on Day 1 | 103.7 | — |
| AUC24 on Day 14 or 21 | 201.6 | — |
| AUCtau1 on Day 14 or 21 | 85.57 | — |
| AUCtau2 on Day 14 or 21 | 115.4 | — |
| AUC24 on Day 28 | 455.9 | — |
| AUCtau1 on Day 28 | 190.8 | — |
| AUCtau2 on Day 28 | 261.0 | — |
| PF-06882961 120mg BID ST (Cohort 6)AUC24 on Day 1 | 324.0 | — |
| AUCtau1 on Day 1 | 147.7 | — |
| AUCtau2 on Day 1 | 176.4 | — |
| AUC24 on Day 14 or 21 | 2660 | — |
| AUCtau1 on Day 14 or 21 | 957.3 | — |
| AUCtau2 on Day 14 or 21 | 1693 | — |
| AUC24 on Day 28 | 5973 | — |
| AUCtau1 on Day 28 | 2249 | — |
| AUCtau2 on Day 28 | 3668 | — |
| PF-06882961 200mg QD CR (Cohort 7)AUC24 on Day 1 | 393.9 | — |
| AUCtau1 on Day 1 | NA | — |
| AUCtau2 on Day 1 | NA | — |
| AUC24 on Day 14 or 21 | 1291 | — |
| AUCtau1 on Day 14 or 21 | NA | — |
| AUCtau2 on Day 14 or 21 | NA | — |
| AUC24 on Day 28 | 4372 | — |
| AUCtau1 on Day 28 | NA | — |
| AUCtau2 on Day 28 | NA | — |
| PF-06882961 120mg QD (Cohort 8)AUC24 on Day 1 | 184.6 | — |
| AUCtau1 on Day 1 | NA | — |
| AUCtau2 on Day 1 | NA | — |
| AUC24 on Day 14 or 21 | 1204 | — |
| AUCtau1 on Day 14 or 21 | NA | — |
| AUCtau2 on Day 14 or 21 | NA | — |
| AUC24 on Day 28 | 2723 | — |
| AUCtau1 on Day 28 | NA | — |
| AUCtau2 on Day 28 | NA | — |
Secondary/protocol endpoint
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Time frame:0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28
Cmax
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanogram/milliliter (ng/mL) | 95% CI |
|---|---|---|
| PF-06882961 15mg BID (Cohort 1)Cmax on Day 1 | 50.58 | — |
| Cmax1 on Day 1 | 42.69 | — |
| Cmax2 on Day 1 | 40.63 | — |
| Cmax on Day 14 or 21 | 65.78 | — |
| Cmax1 on Day 14 or 21 | 55.00 | — |
| Cmax2 on Day 14 or 21 | 63.89 | — |
| Cmax on Day 28 | 81.56 | — |
| Cmax1 on Day 28 | 50.24 | — |
| Cmax2 on Day 28 | 74.22 | — |
| PF-06882961 50mg BID (Cohort 2)Cmax on Day 1 | 124.4 | — |
| Cmax1 on Day 1 | 119.1 | — |
| Cmax2 on Day 1 | 68.77 | — |
| Cmax on Day 14 or 21 | 149.8 | — |
| Cmax1 on Day 14 or 21 | 130.2 | — |
| Cmax2 on Day 14 or 21 | 127.9 | — |
| Cmax on Day 28 | 133.7 | — |
| Cmax1 on Day 28 | 103.8 | — |
| Cmax2 on Day 28 | 117.2 | — |
| PF-06882961 70mg BID (Cohort 3)Cmax on Day 1 | 49.75 | — |
| Cmax1 on Day 1 | 45.01 | — |
| Cmax2 on Day 1 | 42.33 | — |
| Cmax on Day 14 or 21 | 253.6 | — |
| Cmax1 on Day 14 or 21 | 235.1 | — |
| Cmax2 on Day 14 or 21 | 202.8 | — |
| Cmax on Day 28 | 328.8 | — |
| Cmax1 on Day 28 | 197.9 | — |
| Cmax2 on Day 28 | 306.5 | — |
| PF-06882961 120mg BID (Cohort 4)Cmax on Day 1 | 51.61 | — |
| Cmax1 on Day 1 | 36.51 | — |
| Cmax2 on Day 1 | 44.97 | — |
| Cmax on Day 14 or 21 | 788.4 | — |
| Cmax1 on Day 14 or 21 | 682.7 | — |
| Cmax2 on Day 14 or 21 | 505.3 | — |
| Cmax on Day 28 | 685.2 | — |
| Cmax1 on Day 28 | 649.2 | — |
| Cmax2 on Day 28 | 617.9 | — |
| PF-06882961 10mg BID (Cohort 5)Cmax on Day 1 | 15.02 | — |
| Cmax1 on Day 1 | 12.82 | — |
| Cmax2 on Day 1 | 13.98 | — |
| Cmax on Day 14 or 21 | 18.63 | — |
| Cmax1 on Day 14 or 21 | 15.31 | — |
| Cmax2 on Day 14 or 21 | 17.16 | — |
| Cmax on Day 28 | 38.38 | — |
| Cmax1 on Day 28 | 30.42 | — |
| Cmax2 on Day 28 | 35.01 | — |
| PF-06882961 120mg BID ST (Cohort 6)Cmax on Day 1 | 26.02 | — |
| Cmax1 on Day 1 | 24.06 | — |
| Cmax2 on Day 1 | 21.64 | — |
| Cmax on Day 14 or 21 | 188.5 | — |
| Cmax1 on Day 14 or 21 | 143.0 | — |
| Cmax2 on Day 14 or 21 | 178.4 | — |
| Cmax on Day 28 | 437.6 | — |
| Cmax1 on Day 28 | 357.1 | — |
| Cmax2 on Day 28 | 410.3 | — |
| PF-06882961 200mg QD CR (Cohort 7)Cmax on Day 1 | 28.67 | — |
| Cmax1 on Day 1 | NA | — |
| Cmax2 on Day 1 | NA | — |
| Cmax on Day 14 or 21 | 98.11 | — |
| Cmax1 on Day 14 or 21 | NA | — |
| Cmax2 on Day 14 or 21 | NA | — |
| Cmax on Day 28 | 303.9 | — |
| Cmax1 on Day 28 | NA | — |
| Cmax2 on Day 28 | NA | — |
| PF-06882961 120mg QD (Cohort 8)Cmax on Day 1 | 20.40 | — |
| Cmax1 on Day 1 | NA | — |
| Cmax2 on Day 1 | NA | — |
| Cmax on Day 14 or 21 | 100.7 | — |
| Cmax1 on Day 14 or 21 | NA | — |
| Cmax2 on Day 14 or 21 | NA | — |
| Cmax on Day 28 | 192.2 | — |
| Cmax1 on Day 28 | NA | — |
| Cmax2 on Day 28 | NA | — |
Secondary/protocol endpoint
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Time frame:0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
Tmax
descriptive
Posted result
| Group | Value (median), hours | 95% CI |
|---|---|---|
| PF-06882961 15mg BID (Cohort 1)Tmax on Day 1 | NA | NA – NA |
| Tmax1 on Day 1 | 4.00 | 2.00 – 8.00 |
| Tmax2 on Day 1 | 14.0 | 10.0 – 24.0 |
| Tmax on Day 14 or 21 | NA | NA – NA |
| Tmax1 on Day 14 or 21 | 4.00 | 2.00 – 8.00 |
| Tmax2 on Day 14 or 21 | 13.0 | 12.0 – 14.0 |
| Tmax on Day 28 | NA | NA – NA |
| Tmax1 on Day 28 | 5.00 | 4.00 – 8.00 |
| Tmax2 on Day 28 | 12.0 | 12.0 – 14.0 |
| PF-06882961 50mg BID (Cohort 2)Tmax on Day 1 | NA | NA – NA |
| Tmax1 on Day 1 | 4.00 | 1.00 – 6.00 |
| Tmax2 on Day 1 | 14.0 | 10.0 – 24.0 |
| Tmax on Day 14 or 21 | NA | NA – NA |
| Tmax1 on Day 14 or 21 | 4.00 | 1.00 – 6.00 |
| Tmax2 on Day 14 or 21 | 13.0 | 10.0 – 14.0 |
| Tmax on Day 28 | NA | NA – NA |
| Tmax1 on Day 28 | 3.00 | 0.00 – 8.00 |
| Tmax2 on Day 28 | 12.0 | 12.0 – 12.0 |
| PF-06882961 70mg BID (Cohort 3)Tmax on Day 1 | NA | NA – NA |
| Tmax1 on Day 1 | 2.00 | 1.00 – 6.00 |
| Tmax2 on Day 1 | 14.0 | 12.0 – 14.0 |
| Tmax on Day 14 or 21 | NA | NA – NA |
| Tmax1 on Day 14 or 21 | 1.05 | 1.00 – 6.00 |
| Tmax2 on Day 14 or 21 | 12.0 | 12.0 – 12.0 |
| Tmax on Day 28 | NA | NA – NA |
| Tmax1 on Day 28 | 6.00 | 2.00 – 8.00 |
| Tmax2 on Day 28 | 12.0 | 12.0 – 14.0 |
| PF-06882961 120mg BID (Cohort 4)Tmax on Day 1 | NA | NA – NA |
| Tmax1 on Day 1 | 4.00 | 2.00 – 6.00 |
| Tmax2 on Day 1 | 14.0 | 12.0 – 24.0 |
| Tmax on Day 14 or 21 | NA | NA – NA |
| Tmax1 on Day 14 or 21 | 1.54 | 1.00 – 6.00 |
| Tmax2 on Day 14 or 21 | 12.0 | 10.0 – 14.0 |
| Tmax on Day 28 | NA | NA – NA |
| Tmax1 on Day 28 | 4.00 | 1.00 – 6.00 |
| Tmax2 on Day 28 | 12.0 | 12.0 – 14.0 |
| PF-06882961 10mg BID (Cohort 5)Tmax on Day 1 | NA | NA – NA |
| Tmax1 on Day 1 | 2.00 | 1.00 – 2.00 |
| Tmax2 on Day 1 | 12.0 | 12.0 – 14.0 |
| Tmax on Day 14 or 21 | NA | NA – NA |
| Tmax1 on Day 14 or 21 | 6.00 | 1.00 – 6.00 |
| Tmax2 on Day 14 or 21 | 12.0 | 12.0 – 14.0 |
| Tmax on Day 28 | NA | NA – NA |
| Tmax1 on Day 28 | 4.00 | 2.00 – 8.00 |
| Tmax2 on Day 28 | 12.0 | 12.0 – 14.0 |
| PF-06882961 120mg BID ST (Cohort 6)Tmax on Day 1 | NA | NA – NA |
| Tmax1 on Day 1 | 2.00 | 1.00 – 4.00 |
| Tmax2 on Day 1 | 14.0 | 12.0 – 24.0 |
| Tmax on Day 14 or 21 | NA | NA – NA |
| Tmax1 on Day 14 or 21 | 6.00 | 4.00 – 10.0 |
| Tmax2 on Day 14 or 21 | 14.0 | 12.0 – 24.0 |
| Tmax on Day 28 | NA | NA – NA |
| Tmax1 on Day 28 | 6.00 | 4.00 – 10.0 |
| Tmax2 on Day 28 | 12.0 | 10.0 – 14.0 |
| PF-06882961 200mg QD CR (Cohort 7)Tmax on Day 1 | 13.0 | 8.00 – 23.9 |
| Tmax1 on Day 1 | NA | NA – NA |
| Tmax2 on Day 1 | NA | NA – NA |
| Tmax on Day 14 or 21 | 12.0 | 6.00 – 14.0 |
| Tmax1 on Day 14 or 21 | NA | NA – NA |
| Tmax2 on Day 14 or 21 | NA | NA – NA |
| Tmax on Day 28 | 14.0 | 8.00 – 14.0 |
| Tmax1 on Day 28 | NA | NA – NA |
| Tmax2 on Day 28 | NA | NA – NA |
| PF-06882961 120mg QD (Cohort 8)Tmax on Day 1 | 3.00 | 1.00 – 6.00 |
| Tmax1 on Day 1 | NA | NA – NA |
| Tmax2 on Day 1 | NA | NA – NA |
| Tmax on Day 14 or 21 | 6.00 | 4.00 – 10.0 |
| Tmax1 on Day 14 or 21 | NA | NA – NA |
| Tmax2 on Day 14 or 21 | NA | NA – NA |
| Tmax on Day 28 | 10.0 | 6.00 – 14.0 |
| Tmax1 on Day 28 | NA | NA – NA |
| Tmax2 on Day 28 | NA | NA – NA |
Secondary/protocol endpoint
Terminal Half-life (t½) of PF-06882961 on Day 28
Time frame:0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28
Half-life
descriptive
Posted result
| Group | Value (mean), hours | 95% CI |
|---|---|---|
| PF-06882961 15mg BID (Cohort 1) | 5.100 | — |
| PF-06882961 50mg BID (Cohort 2) | 5.067 | — |
| PF-06882961 70mg BID (Cohort 3) | 4.681 | — |
| PF-06882961 120mg BID (Cohort 4) | 6.203 | — |
| PF-06882961 10mg BID (Cohort 5) | 8.090 | — |
| PF-06882961 120mg BID ST (Cohort 6) | 6.730 | — |
| PF-06882961 200mg QD CR (Cohort 7) | 5.773 | — |
| PF-06882961 120mg QD (Cohort 8) | 4.954 | — |
Secondary/protocol endpoint
Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28
Time frame:0 to 24 hours post-dose on Day 28
descriptive
Posted result
| Group | Value (geometric_mean), microgram | 95% CI |
|---|---|---|
| PF-06882961 15mg BID (Cohort 1) | 17.25 | — |
| PF-06882961 50mg BID (Cohort 2) | 33.60 | — |
| PF-06882961 70mg BID (Cohort 3) | 41.16 | — |
| PF-06882961 120mg BID (Cohort 4) | NA | — |
| PF-06882961 10mg BID (Cohort 5) | 14.97 | — |
| PF-06882961 120mg BID ST (Cohort 6) | 62.63 | — |
| PF-06882961 200mg QD CR (Cohort 7) | 72.98 | — |
| PF-06882961 120mg QD (Cohort 8) | 49.09 | — |
Secondary/protocol endpoint
Ae24 (%) of PF-06882961 on Day 28
Time frame:0 to 24 hours post-dose on Day 28
percent change from baseline, descriptive
Posted result
| Group | Value (geometric_mean), Percentage | 95% CI |
|---|---|---|
| PF-06882961 15mg BID (Cohort 1) | 0.05747 | — |
| PF-06882961 50mg BID (Cohort 2) | 0.03360 | — |
| PF-06882961 70mg BID (Cohort 3) | 0.02942 | — |
| PF-06882961 120mg BID (Cohort 4) | NA | — |
| PF-06882961 10mg BID (Cohort 5) | 0.07483 | — |
| PF-06882961 120mg BID ST (Cohort 6) | 0.02607 | — |
| PF-06882961 200mg QD CR (Cohort 7) | 0.03652 | — |
| PF-06882961 120mg QD (Cohort 8) | 0.04094 | — |
Secondary/protocol endpoint
Renal Clearance (CLr) of PF-06882961 on Day 28
Time frame:0 to 24 hours post-dose on Day 28
descriptive
Posted result
| Group | Value (geometric_mean), mL/min | 95% CI |
|---|---|---|
| PF-06882961 15mg BID (Cohort 1) | 0.3273 | — |
| PF-06882961 50mg BID (Cohort 2) | 0.3385 | — |
| PF-06882961 70mg BID (Cohort 3) | 0.3094 | — |
| PF-06882961 120mg BID (Cohort 4) | NA | — |
| PF-06882961 10mg BID (Cohort 5) | 0.5470 | — |
| PF-06882961 120mg BID ST (Cohort 6) | 0.2006 | — |
| PF-06882961 200mg QD CR (Cohort 7) | 0.2895 | — |
| PF-06882961 120mg QD (Cohort 8) | 0.3178 | — |
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
- Nature medicine2021 Jun (month)PMID34127852doi:10.1038/s41591-021-01391-wvia clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.