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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06670170

Enrollment

Registered

2024-11-01

Start date

2024-11-05

Completion date

2025-01-17

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Healthy Participants, Healthy Subjects, Human Volunteers, Normal Volunteers

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.

Interventions

DRUGPF-07976016 Formulation A

PF-07976016; formulation A - current/reference

DRUGPF-07976016 Formulation B

PF-07976016; Formulation B - new/test

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026