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RECRUITING
NCT07231991
PHASE1

A Study to Learn How the Body Processes the Study Medicine Called Vepdegestrant in People With Loss of Liver Function

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

The purpose of the study is to look at how the body processes a study medicine called vepdegestrant in participants with loss of liver function relative to people with normal liver function. This study is seeking participants who are: * females who cannot have children or males * between 18 and 70 years of age * weigh more than 50 Kilograms (110 pounds) * either healthy with normal liver function or have loss of liver function All participants in this study will take one dose of vepdegestrant by mouth. This study looks at how the medicine is changed and removed from the body after being taken by the participants. The amount of vepdegestrant in participants with loss of liver function will be compared to the amount of vepdegestrant in participants with normal liver function. All participants will stay at the study clinic for about 11 days and 10 nights.

Official title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF VEPDEGESTRANT (PF-07850327) IN ADULT PARTICIPANTS WITH MODERATE AND SEVERE HEPATIC IMPAIRMENT RELATIVE TO HEALTHY PARTICIPANTS WITH NORMAL HEPATIC FUNCTION

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-11-18

Completion Date

2026-12-23

Last Updated

2026-04-03

Healthy Volunteers

Yes

Interventions

DRUG

vepdegestrant

Vepdegestrant administered as a single oral 200 mg dose

Locations (4)

Clinical Pharmacology of Miami

Miami, Florida, United States

Floridian Clinical Research, LLC

Miami Lakes, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Genesis Clinical Research, LLC

Tampa, Florida, United States