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

NCT06670170 | Completed Phase 1 FDA Drug

• 2 other identifiers: C5541005NCT06670170
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy Participants; Healthy Subjects; Human Volunteers; Normal Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

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; Drug: PF-07976016 Formulation B

Sequence 2

EXPERIMENTAL

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; Drug: PF-07976016 Formulation B

Interventions

PF-07976016 Formulation A DRUG

PF-07976016; formulation A - current/reference

Sequence 1; Sequence 2

PF-07976016 Formulation B DRUG

PF-07976016; Formulation B - new/test

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: November 5, 2024
• Primary Completion: December 24, 2024
• Study Completion: January 17, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)