A Study to Learn How Different Amounts of the Study Medicine Called PF-07976016 Are Tolerated and Act in The Body in Healthy Adults
Phase 1
Active, not recruiting
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT06106009
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this clinical trial is to learn if the study medicine (called PF-07976016) is safe and how it goes in and out of the body in healthy people. The study may also explore if PF-07976016 has the potential to interact with another medicine called midazolam. In addition, the study may explore how PF-07976016 goes into the body of people who have obesity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
- Male and female participants of non-childbearing potential aged 18 to 65 years, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- A total body weight >50 kg (110 lb).
- Parts A, B and C only: BMI of 20-33 kg/m2.
- Part D only: BMI of 30-40 kg/m2 and may have well controlled hyperlipidemia or hypertension.
Key
Exclusion Criteria
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Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, skin or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
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Any condition possibly affecting drug absorption.
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Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
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Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
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Renal impairment as defined by an estimated glomerular filtration rate of <75 mL/min/1.73 m².
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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:
- alanine aminotransferase, aspartate aminotransferase, or bilirubin ≥1.05 × upper limit of normal;
- fasting plasma glucose > 126 mg/dL;
- HbA1c ≥6.0% (Parts A,B and C); HbA1c ≥6.5% (Part D);
- hematuria as defined by ≥1+ heme on urine dipstick;
- albuminuria as defined by urine albumin/creatinine ratio >30 mg/g.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A Cohort 1 Placebo Single dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo. Part A Cohort 2 PF-07976016 Single dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo. Part A Cohort 1 PF-07976016 Single dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo. Part A Cohort 2 Placebo Single dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo. Part A Optional Cohort 3 PF-07976016 Single dose administration of PF-07976016 and placebo. Participants will receive up to 2 dose levels of PF-07976016 or matching placebo. Part A Optional Cohort 3 Placebo Single dose administration of PF-07976016 and placebo. Participants will receive up to 2 dose levels of PF-07976016 or matching placebo. Part A Optional Cohort 4 Placebo Single dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo. Part B Cohort 5 Placebo Multiple dose administration of PF-07976016 or matching placebo. Part B Cohort 6 PF-07976016 Multiple dose administration of PF-07976016 or matching placebo. Part B Cohort 6 Placebo Multiple dose administration of PF-07976016 or matching placebo. Part B Cohort 7 PF-07976016 Multiple dose administration of PF-07976016 or matching placebo. Part B Cohort 7 Placebo Multiple dose administration of PF-07976016 or matching placebo. Part B Cohort 8 PF-07976016 Multiple dose administration of PF-07976016 or matching placebo. Part B Cohort 8 Placebo Multiple dose administration of PF-07976016 or matching placebo. Part B Cohort 9 PF-07976016 Multiple dose administration of PF-07976016 or matching placebo. Part B Cohort 9 Placebo Multiple dose administration of PF-07976016 or matching placebo. Part B Optional Cohort 10 PF-07976016 Multiple dose administration of PF-07976016 or matching placebo. Part B Optional Cohort 10 Placebo Multiple dose administration of PF-07976016 or matching placebo. Part D Optional Cohort 13 Placebo Multiple dose administration of PF-07976016 or matching placebo. Part B Cohort 5 PF-07976016 Multiple dose administration of PF-07976016 or matching placebo. Part C Optional Cohort 12 PF-07976016 Single dose midazolam administered alone or in combination with multiple doses of PF-07976016. Part A Optional Cohort 4 PF-07976016 Single dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo. Part D Optional Cohort 13 PF-07976016 Multiple dose administration of PF-07976016 or matching placebo. Part C Optional Cohort 11 PF-07976016 Single dose midazolam administered alone or in combination with multiple doses of PF-07976016. Part C Optional Cohort 11 Midazolam Single dose midazolam administered alone or in combination with multiple doses of PF-07976016. Part C Optional Cohort 12 Midazolam Single dose midazolam administered alone or in combination with multiple doses of PF-07976016.
- Primary Outcome Measures
Name Time Method Part A: Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Single Doses Day 1 up to approximately Day 36 Part B, Parts C and D, if conducted: Number of Participants With Treatment Emergent Adverse Events Following Multiple Doses Day 1 up to approximately Day 49 Part A: Number of Participants With Treatment Emergent Adverse Events Following Single Doses Day 1 up to approximately Day 36 Part A: Number of Participants With Clinical Laboratory Abnormalities Following Single Doses Day 1 up to approximately Day 36 Part A: Number of Participants With Clinically Significant Change in Baseline Vital Signs Following Single Doses Day 1 up to approximately Day 36 Part B, Parts C and D, if conducted: Number of Participants With Clinically Significant Change in Baseline Vital Signs Following Multiple Doses Day 1 up to approximately Day 49 Part B, Parts C and D, if conducted: Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Multiple Doses Day 1 up to approximately Day 49 Part B, Parts C and D, if conducted: Number of Participants With Clinical Laboratory Abnormalities Following Multiple Doses Day 1 up to approximately Day 49
- Secondary Outcome Measures
Name Time Method Part B: Plasma Half-Life Day 14 Part B: Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau Day 14 Part B: Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau Day 14 Part B: Renal Clearance of Drug Day 14 Part C (if conducted): Maximum Observed Plasma Concentration of Midazolam Day 1, Day 3 and Day 11 Part C (if conducted): Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration of Midazolam Day 1, Day 3 and Day 11 Part C (if conducted): Area Under the Curve From Time Zero to Extrapolated Infinite Time of Midazolam Day 1, Day 3 and Day 11 Part D (if conducted): Maximum Observed Plasma Concentration of PF-07976016 Days 1 and 14 Part D (if conducted): Time to Reach Maximum Observed Plasma Concentration of PF-07976016 Days 1 and 14 Part D (if conducted): Plasma Half-Life of PF-07976016 Day 14 Part A: Maximum Observed Plasma Concentration Day 1 up to Day 4 Part D (if conducted): Area Under the Curve From Time Zero to Time Tau of PF-07976016 Days 1 and 14 Part A: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration Day 1 up to Day 4 Part A: Time to Reach Maximum Observed Plasma Concentration Day 1 up to Day 4 Part A: Area Under the Curve From Time Zero to Extrapolated Infinite Time Day 1 up to Day 4 Part A: Plasma Half-Life Day 1 up to Day 4 Part B: Maximum Observed Plasma Concentration Days 1, 7 and 14 Part B: Time to Reach Maximum Observed Plasma Concentration Days 1, 7 and 14 Part B: Area Under the Curve From Time Zero to Time Tau Days 1, 7 and 14
Trial Locations
- Locations (1)
Pfizer Clinical Research Unit - New Haven
🇺🇸New Haven, Connecticut, United States