Skip to main content
OpenTrials
Completed

NCT Number: NCT06670170

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-07976016 Formulation A

Drug

PF-07976016; formulation A - current/reference

PF-07976016 Formulation B

Drug

PF-07976016; Formulation B - new/test

Primary outcomes

  1. Area Under the Curve - infinity - AUCinf (as data permit, otherwise AUClast).

    Time frame: Day 1 Hour 0 (pre-dose) through 168 hours post dose in each period

Secondary outcomes

  1. Incidence of Treatment Emergent Adverse Events - TEAEs

    Time frame: From first dose (Day 1) up to 28-35 days after final dose; a total of approximately 51 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.