Skip to main content
OpenTrials
Completed

NCT Number: NCT06106009

A Study to Learn How Different Amounts of the Study Medicine Called PF-07976016 Are Tolerated and Act in The Body in Healthy Adults

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key 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:

  • 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).
  • Any condition possibly affecting drug absorption.
  • 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.
  • Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
  • Renal impairment as defined by an estimated glomerular filtration rate of <75 mL/min/1.73 m².
  • 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.

Treatment and study plan

PF-07976016

Drug

Oral solution, oral suspension or solid oral formulation(s)

Placebo

Drug

Oral solution, oral suspension or solid oral formulation(s)

midazolam

Drug

Midazolam oral solution

Primary outcomes

  1. Part A: Number of Participants With Treatment Emergent Adverse Events Following Single Doses

    Time frame: Day 1 up to approximately Day 36

  2. Part A: Number of Participants With Clinical Laboratory Abnormalities Following Single Doses

    Time frame: Day 1 up to approximately Day 36

  3. Part A: Number of Participants With Clinically Significant Change in Baseline Vital Signs Following Single Doses

    Time frame: Day 1 up to approximately Day 36

  4. Part A: Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Single Doses

    Time frame: Day 1 up to approximately Day 36

  5. Part B, Parts C and D, if conducted: Number of Participants With Treatment Emergent Adverse Events Following Multiple Doses

    Time frame: Day 1 up to approximately Day 49

  6. Part B, Parts C and D, if conducted: Number of Participants With Clinical Laboratory Abnormalities Following Multiple Doses

    Time frame: Day 1 up to approximately Day 49

  7. Part B, Parts C and D, if conducted: Number of Participants With Clinically Significant Change in Baseline Vital Signs Following Multiple Doses

    Time frame: Day 1 up to approximately Day 49

  8. Part B, Parts C and D, if conducted: Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Multiple Doses

    Time frame: Day 1 up to approximately Day 49

Secondary outcomes

  1. Part A: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration

    Time frame: Day 1 up to Day 4

  2. Part A: Maximum Observed Plasma Concentration

    Time frame: Day 1 up to Day 4

  3. Part A: Time to Reach Maximum Observed Plasma Concentration

    Time frame: Day 1 up to Day 4

  4. Part A: Area Under the Curve From Time Zero to Extrapolated Infinite Time

    Time frame: Day 1 up to Day 4

  5. Part A: Plasma Half-Life

    Time frame: Day 1 up to Day 4

  6. Part B: Maximum Observed Plasma Concentration

    Time frame: Days 1, 7 and 14

  7. Part B: Time to Reach Maximum Observed Plasma Concentration

    Time frame: Days 1, 7 and 14

  8. Part B: Area Under the Curve From Time Zero to Time Tau

    Time frame: Days 1, 7 and 14

  9. Part B: Plasma Half-Life

    Time frame: Day 14

  10. Part B: Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau

    Time frame: Day 14

  11. Part B: Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau

    Time frame: Day 14

  12. Part B: Renal Clearance of Drug

    Time frame: Day 14

  13. Part C (if conducted): Maximum Observed Plasma Concentration of Midazolam

    Time frame: Day 1, Day 3 and Day 11

  14. Part C (if conducted): Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration of Midazolam

    Time frame: Day 1, Day 3 and Day 11

  15. Part C (if conducted): Area Under the Curve From Time Zero to Extrapolated Infinite Time of Midazolam

    Time frame: Day 1, Day 3 and Day 11

  16. Part D (if conducted): Maximum Observed Plasma Concentration of PF-07976016

    Time frame: Days 1 and 14

  17. Part D (if conducted): Time to Reach Maximum Observed Plasma Concentration of PF-07976016

    Time frame: Days 1 and 14

  18. Part D (if conducted): Area Under the Curve From Time Zero to Time Tau of PF-07976016

    Time frame: Days 1 and 14

  19. Part D (if conducted): Plasma Half-Life of PF-07976016

    Time frame: Day 14

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multi-Part, Phase 1 Study With Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single- And Multiple-Dose Escalation To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-07976016 In Healthy Adult Participants

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2023
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.