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

A PHASE 1, OPEN-LABEL, RANDOMIZED CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF TWO FORMULATIONS OF PF-07976016 ADMINISTERED ORALLY TO HEALTHY ADULT PARTICIPANTS

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: PF-07976016 Formulation A; Drug: PF-07976016 Formulation B

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Clinical Research Unit - New Haven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Key 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; 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.	Drug: PF-07976016 Formulation A; PF-07976016; formulation A - current/reference; Drug: PF-07976016 Formulation B; PF-07976016; Formulation B - new/test
Experimental: Sequence 2; 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.	Drug: PF-07976016 Formulation A; PF-07976016; formulation A - current/reference; Drug: PF-07976016 Formulation B; PF-07976016; Formulation B - new/test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Actual): December 24, 2024
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Subjects; Healthy Participants; Human Volunteers; Normal Volunteers
• Other Study ID Numbers: C5541005; NCT06670170 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No