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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-27

Study Completion Date

2024-08-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Parts A, B and D are double-blinded and sponsor-open while Part C is open-label.

Study Groups

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Part A Cohort 1

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

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Part A Cohort 2

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

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Part A Optional Cohort 3

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

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Part A Optional Cohort 4

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

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Part B Cohort 5

Multiple dose administration of PF-07976016 or matching placebo.

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Part B Cohort 6

Multiple dose administration of PF-07976016 or matching placebo.

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Part B Cohort 7

Multiple dose administration of PF-07976016 or matching placebo.

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Part B Cohort 8

Multiple dose administration of PF-07976016 or matching placebo.

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Part B Cohort 9

Multiple dose administration of PF-07976016 or matching placebo.

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Part B Optional Cohort 10

Multiple dose administration of PF-07976016 or matching placebo.

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Part C Optional Cohort 11

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

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Midazolam

Intervention Type DRUG

Midazolam oral solution

Part C Optional Cohort 12

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

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Midazolam

Intervention Type DRUG

Midazolam oral solution

Part D Optional Cohort 13

Multiple dose administration of PF-07976016 or matching placebo.

Group Type EXPERIMENTAL

PF-07976016

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

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PF-07976016

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Midazolam

Midazolam oral solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. A total body weight \>50 kg (110 lb).
3. Parts A, B and C only: BMI of 20-33 kg/m2.
4. Part D only: BMI of 30-40 kg/m2 and may have well controlled hyperlipidemia or hypertension.

Exclusion Criteria

1. 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).
2. Any condition possibly affecting drug absorption.
3. 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.
4. Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
5. Renal impairment as defined by an estimated glomerular filtration rate of \<75 mL/min/1.73 m².
6. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes