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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-04

Study Completion Date

2026-12-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Learn How Various Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood of Healthy Adults

NCT06347861

Healthy

COMPLETED PHASE1

A Study to Learn How Different Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood in Healthy Adults

NCT06645938

Healthy

COMPLETED PHASE1

A Study to Learn How a Tablet Compared With an IV Infusion of the Study Medicine Called Vepdegestrant is Taken up Into the Blood in Healthy Adults

NCT06911788

Healthy Participants

COMPLETED PHASE1

A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems

NCT06957756

Hepatic Insufficiency

RECRUITING PHASE1

A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems

NCT05661344

Hepatic Insufficiency

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

participants with normal hepatic function

Group Type EXPERIMENTAL

vepdegestrant

Intervention Type DRUG

Vepdegestrant administered as a single oral 200 mg dose

Group 2

participants with moderate hepatic impairment

Group Type EXPERIMENTAL

vepdegestrant

Intervention Type DRUG

Vepdegestrant administered as a single oral 200 mg dose

Group 3

participants with severe hepatic impairment

Group Type EXPERIMENTAL

vepdegestrant

Intervention Type DRUG

Vepdegestrant administered as a single oral 200 mg dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vepdegestrant

Vepdegestrant administered as a single oral 200 mg dose

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ARV-471, PF-07850327

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female participants of non-childbearing potential, or male participants between the age of 18 years (or the minimum age of consent in accordance with local regulations) and 70 years, inclusive, at screening.
* Body mass index of 17.5-38 kg/m2, inclusive, and a total body weight \>50 kg (110 lb).

Normal hepatic function group only:

-Overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and standard 12-lead ECGs.

Hepatic impairment groups only:

* Satisfy the criteria for Class B (Group 2: moderate hepatic impairment) or C (Group 3: severe hepatic impairment) of the modified Child-Pugh Classification.
* Stable hepatic impairment, defined as no clinically significant change in disease status within the last 28 days prior to the screening visit, as documented by the participant's recent medical history.

Exclusion Criteria

* Any condition possibly affecting drug absorption.
* Use of prohibited prior or concomitant medications.

Normal hepatic function group only:

-Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Hepatic impairment groups only:

-A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes