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

NCT06106009 | Completed Phase 1 FDA Drug

• 1 other identifier: C5541001
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• 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 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 B, Parts C and D, if conducted: Number of Participants With Clinical Laboratory Abnormalities 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 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

Secondary Outcomes (19)

• 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: Maximum Observed Plasma 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

Study Arms (13)

Part A Cohort 1

EXPERIMENTAL

Single dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo.

Drug: PF-07976016; Drug: Placebo

Part A Cohort 2

EXPERIMENTAL

Single dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo.

Drug: PF-07976016; Drug: Placebo

Part A Optional Cohort 3

EXPERIMENTAL

Single dose administration of PF-07976016 and placebo. Participants will receive up to 2 dose levels of PF-07976016 or matching placebo.

Drug: PF-07976016; Drug: Placebo

Part A Optional Cohort 4

EXPERIMENTAL

Single dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo.

Drug: PF-07976016; Drug: Placebo

Part B Cohort 5

EXPERIMENTAL

Multiple dose administration of PF-07976016 or matching placebo.

Drug: PF-07976016; Drug: Placebo

Part B Cohort 6

EXPERIMENTAL

Multiple dose administration of PF-07976016 or matching placebo.

Drug: PF-07976016; Drug: Placebo

Part B Cohort 7

EXPERIMENTAL

Multiple dose administration of PF-07976016 or matching placebo.

Drug: PF-07976016; Drug: Placebo

Part B Cohort 8

EXPERIMENTAL

Multiple dose administration of PF-07976016 or matching placebo.

Drug: PF-07976016; Drug: Placebo

Part B Cohort 9

EXPERIMENTAL

Multiple dose administration of PF-07976016 or matching placebo.

Drug: PF-07976016; Drug: Placebo

Part B Optional Cohort 10

EXPERIMENTAL

Multiple dose administration of PF-07976016 or matching placebo.

Drug: PF-07976016; Drug: Placebo

Part C Optional Cohort 11

EXPERIMENTAL

Single dose midazolam administered alone or in combination with multiple doses of PF-07976016.

Drug: PF-07976016; Drug: Midazolam

Part C Optional Cohort 12

EXPERIMENTAL

Single dose midazolam administered alone or in combination with multiple doses of PF-07976016.

Drug: PF-07976016; Drug: Midazolam

Part D Optional Cohort 13

EXPERIMENTAL

Multiple dose administration of PF-07976016 or matching placebo.

Drug: PF-07976016; Drug: Placebo

Interventions

PF-07976016 DRUG

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

Part A Cohort 1; Part A Cohort 2; Part A Optional Cohort 3; Part A Optional Cohort 4; Part B Cohort 5; Part B Cohort 6; Part B Cohort 7; Part B Cohort 8; Part B Cohort 9; Part B Optional Cohort 10; Part C Optional Cohort 11; Part C Optional Cohort 12; Part D Optional Cohort 13

Placebo DRUG

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

Part A Cohort 1; Part A Cohort 2; Part A Optional Cohort 3; Part A Optional Cohort 4; Part B Cohort 5; Part B Cohort 6; Part B Cohort 7; Part B Cohort 8; Part B Cohort 9; Part B Optional Cohort 10; Part D Optional Cohort 13

Midazolam DRUG

Midazolam oral solution

Part C Optional Cohort 11; Part C Optional Cohort 12

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Parts A, B and D are double-blinded and sponsor-open while Part C is open-label.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A and B are randomized, double-blinded, sponsor-open, placebo-controlled studies to evaluate safety, tolerability, PK and PD of single and multiple escalating oral doses of PF-07976016 in healthy adult participants, respectively. Part A is a crossover while Part B is a parallel cohort study design. Part A of the study may also evaluate the safety, tolerability and PK in Japanese participants. Part C is an optional open-label, 4-period, fixed-sequence study to evaluate the effect of PF-07976016 on midazolam PK in healthy participants. Part D is an optional sponsor-open, randomized, double-blinded, placebo-controlled multiple dose study of PF-07976016 administered to participants with obesity.

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: October 27, 2023
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)