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

NCT07231991 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: C4891004
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• Maximum observed concentration (Cmax) for vepdegestrant

  Pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, and 216 hours post dose

• Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for vepdegestrant

  AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

  Pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, and 216 hours post dose

Secondary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events

  Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.

• Number of Participants With Clinically Significant Clinical Laboratory Abnormalities

  Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.

• Number of Participants With Clinically Significant Change From Baseline in Vital Signs

  Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.

• Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

  Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.

Study Arms (3)

Group 1

EXPERIMENTAL

participants with normal hepatic function

Drug: vepdegestrant

Group 2

EXPERIMENTAL

participants with moderate hepatic impairment

Drug: vepdegestrant

Group 3

EXPERIMENTAL

participants with severe hepatic impairment

Drug: vepdegestrant

Interventions

vepdegestrant DRUG

Vepdegestrant administered as a single oral 200 mg dose

Also known as: ARV-471, PF-07850327

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead
• Arvinas Estrogen Receptor, Inc.: collaborator

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): November 29, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share