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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-07976016; Drug: Placebo; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT06106009

C5541001

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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117 participants in 13 patient groups

Part A Cohort 1

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-07976016

Part A Cohort 2

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-07976016

Part A Optional Cohort 3

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-07976016

Part A Optional Cohort 4

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-07976016

Part B Cohort 5

Experimental group

Description:

Multiple dose administration of PF-07976016 or matching placebo.

Treatment:

Drug: Placebo

Drug: PF-07976016

Part B Cohort 6

Experimental group

Description:

Multiple dose administration of PF-07976016 or matching placebo.

Treatment:

Drug: Placebo

Drug: PF-07976016

Part B Cohort 7

Experimental group

Description:

Multiple dose administration of PF-07976016 or matching placebo.

Treatment:

Drug: Placebo

Drug: PF-07976016

Part B Cohort 8

Experimental group

Description:

Multiple dose administration of PF-07976016 or matching placebo.

Treatment:

Drug: Placebo

Drug: PF-07976016

Part B Cohort 9

Experimental group

Description:

Multiple dose administration of PF-07976016 or matching placebo.

Treatment:

Drug: Placebo

Drug: PF-07976016

Part B Optional Cohort 10

Experimental group

Description:

Multiple dose administration of PF-07976016 or matching placebo.

Treatment:

Drug: Placebo

Drug: PF-07976016

Part C Optional Cohort 11

Experimental group

Description:

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

Treatment:

Drug: Midazolam

Drug: PF-07976016

Part C Optional Cohort 12

Experimental group

Description:

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

Treatment:

Drug: Midazolam

Drug: PF-07976016

Part D Optional Cohort 13

Experimental group

Description:

Multiple dose administration of PF-07976016 or matching placebo.

Treatment:

Drug: Placebo

Drug: PF-07976016