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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106009
• Other study ID #: C5541001
• Status: Recruiting
• Phase: Phase 1
• Start date: October 27, 2023
• Est. completion date: September 5, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: September 5, 2024
• Est. primary completion date: September 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-07976016
Oral solution, oral suspension or solid oral formulation(s)
• Placebo
Oral solution, oral suspension or solid oral formulation(s)
• Midazolam
Midazolam oral solution

Locations

Country	Name	City	State
United States	Pfizer Clinical Research Unit - New Haven	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Number of Participants With Treatment Emergent Adverse Events Following Single Doses		Day 1 up to approximately Day 36
Primary	Part A: Number of Participants With Clinical Laboratory Abnormalities Following Single Doses		Day 1 up to approximately Day 36
Primary	Part A: Number of Participants With Clinically Significant Change in Baseline Vital Signs Following Single Doses		Day 1 up to approximately Day 36
Primary	Part A: Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Single Doses		Day 1 up to approximately Day 36
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Part A: Maximum Observed Plasma Concentration		Day 1 up to Day 4
Secondary	Part A: Time to Reach Maximum Observed Plasma Concentration		Day 1 up to Day 4
Secondary	Part A: Area Under the Curve From Time Zero to Extrapolated Infinite Time		Day 1 up to Day 4
Secondary	Part A: Plasma Half-Life		Day 1 up to Day 4
Secondary	Part B: Maximum Observed Plasma Concentration		Days 1, 7 and 14
Secondary	Part B: Time to Reach Maximum Observed Plasma Concentration		Days 1, 7 and 14
Secondary	Part B: Area Under the Curve From Time Zero to Time Tau		Days 1, 7 and 14
Secondary	Part B: Plasma Half-Life		Day 14
Secondary	Part B: Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau		Day 14
Secondary	Part B: Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau		Day 14
Secondary	Part B: Renal Clearance of Drug		Day 14
Secondary	Part C (if conducted): Maximum Observed Plasma Concentration of Midazolam		Day 1, Day 3 and Day 11
Secondary	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
Secondary	Part C (if conducted): Area Under the Curve From Time Zero to Extrapolated Infinite Time of Midazolam		Day 1, Day 3 and Day 11
Secondary	Part D (if conducted): Maximum Observed Plasma Concentration of PF-07976016		Days 1 and 14
Secondary	Part D (if conducted): Time to Reach Maximum Observed Plasma Concentration of PF-07976016		Days 1 and 14
Secondary	Part D (if conducted): Area Under the Curve From Time Zero to Time Tau of PF-07976016		Days 1 and 14
Secondary	Part D (if conducted): Plasma Half-Life of PF-07976016		Day 14

External Links

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