A Drug-Drug Interaction Study Between PF-06882961 and PF-06865571 in Healthy Adult Participants and Overweight Adults or Adults With Obesity Who Are Otherwise Healthy
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: PF-06882961 Maximum Observed Concentration (Cmax) |
15.69; 17.09 | — |
| PRIMARY Part A: PF-06882961 Area Under the Plasma Concentration-time Profile From Time 0 to the Time 24 Hours Post-dose (AUC24) |
109.5; 123.9 | — |
| PRIMARY Part B: PF-06865571 Cmax on Day 1 and Day 47 |
2078; 791 | — |
| PRIMARY Part B: PF-06865571 Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) on Day 1 and Day 47 |
9011; 6630 | — |
| PRIMARY Part B: PF-06865571 Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) on Day 1 and Day 47 |
9029; 6726 | — |
| PRIMARY Part B: PF-06882961 Cmax on Day 46 and Day 61 |
1187; 1393 | — |
| PRIMARY Part B: PF-06882961 Area Under the Plasma Concentration-time Profile From Time 0 to the Time 12 Hours Post-dose (AUC12) on Day 46 and Day 61 |
7682; 9312 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in Part A |
0; 0 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities in Part A |
2; 3 | — |
| SECONDARY Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part A |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria in Part A |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With TEAEs in Part B |
1; 18; 6; 10; 1; 16 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities in Part B |
0; 16; 0; 15 | — |
| SECONDARY Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part B |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Body Weight for Participants in Part B |
-0.73; -1.49; -2.48; -3.32; -4.76; -5.39 | — |
| SECONDARY Number of Participants With ECG Data Meeting Pre-specified Criteria in Part B |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Suicidal Ideation or Behavior as Per C-SSRS Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) in Part B |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Response to PHQ-9 in Part B |
2; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female participants must be 18 to 65 years of age, inclusive, at the time of signing the ICD.
Women can be of child-bearing potential, however, cannot be pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Male and female participants who are overtly healthy (other than being overweight or obese in Part B only) as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- BMI and total body weight:
Part A: BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb); Part B: BMI ≥25 kg/m2 and not more than 40 kg/m2 at Screening; stable body weight, defined as 450 msec, complete LBBB, signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
- A positive COVID-19 test at or after screening.
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: HbA1c ≥6.5%. AST or ALT > ULN. Total bilirubin level > ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and are eligible for this study provided the direct bilirubin level is ≤ ULN.
TSH > ULN or ULN. Amylase or lipase > ULN. Fasting blood glucose ≥126 mg/dL. Fasting triglycerides >200 mg/dL. INR > ULN. PLT < LLN. eGFR <80 mL/min/1.73 m2 as calculated by the CKD-EPI equation. Positive testing for HIV, HepBsAg, or HCVAb. Study participants positive for HCVAb are to be excluded unless known to have been treated with a known curative therapy and negative for HCV RNA. Hepatitis B vaccination is allowed.
- Participation in a formal weight reduction program (eg, Weight Watchers) within 90 days prior to Screening.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
- Current use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
- Known or suspected illicit drug use.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dose randomization (Day -1).
- History of sensitivity to heparin or heparin-induced thrombocytopenia if Hep-lock is used for IV blood draw.
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Data sourced from ClinicalTrials.gov (NCT04839393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.