A Study to Learn How Different Forms of the Study Medicine Called PF-07976016 Are Taken Up Into the Blood in Healthy Adults

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: PF-07976016 Formulation A; Drug: PF-07976016 Formulation B

• Registration Number: NCT06670170
• Lead Sponsor: Pfizer

Brief Summary

The primary purpose of this study is to measure and compare the amount of study drug in your blood after a single dose of two formulations of study drug.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-10-31
• Study First Posted: 2024-11-01
• Study Start: 2024-11-05
• Primary Completion: 2025-01-14
• Study Completion: 2025-01-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG assessments.
• Willing to provide consent and follow study requirements
• Total body weight >110lbs (50kg)

Key

Exclusion Criteria

• Any condition affecting drug absorption, clinically significant laboratory values
• HIV, HepB & HepC
• Serious illness or hospitalization, or other condition, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Use of prescription or non-prescription drugs within a specified timeframe prior to the first dose of study intervention
• positive urine drug test at screening/admission
• History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
• Use of tobacco/nicotine containing products more than the equivalent of 5 cigarettes/day or 2 chews of tobacco/day

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	PF-07976016 Formulation A	Participants will receive a single dose of PF-07976016 in up to 3 study periods. In sequence 1, participants will receive formulation A followed by formulation B. There will be 7 days between each dose as a wash out period.
Sequence 1	PF-07976016 Formulation B	Participants will receive a single dose of PF-07976016 in up to 3 study periods. In sequence 1, participants will receive formulation A followed by formulation B. There will be 7 days between each dose as a wash out period.
Sequence 2	PF-07976016 Formulation A	Participants will receive single doses of PF-07976016 in up to 3 study periods. In sequence 2, participants will receive formulation B followed by formulation A. There will be 7 days between each dose as a wash out period.
Sequence 2	PF-07976016 Formulation B	Participants will receive single doses of PF-07976016 in up to 3 study periods. In sequence 2, participants will receive formulation B followed by formulation A. There will be 7 days between each dose as a wash out period.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve - infinity - AUCinf (as data permit, otherwise AUClast).	Day 1 Hour 0 (pre-dose) through 168 hours post dose in each period

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events - TEAEs	From first dose (Day 1) up to 28-35 days after final dose; a total of approximately 51 days

Trial Locations

Locations (1)

Pfizer Clinical Research Unit - New Haven; 🇺🇸 New Haven, Connecticut, United States