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

Not Applicable

Not yet recruiting

• Conditions: Healthy Participants
• Interventions: Drug: vepdegestrant

• Registration Number: NCT07231991
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study Start: 2025-11-04
• Study First Submitted: 2025-11-13
• Study First Submitted QC: 2025-11-13
• Last Update Submitted: 2025-11-13
• Study First Posted: 2025-11-17
• Last Update Posted: 2025-11-17
• Primary Completion: 2026-11-29
• Study Completion: 2026-12-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	vepdegestrant	participants with normal hepatic function
Group 2	vepdegestrant	participants with moderate hepatic impairment
Group 3	vepdegestrant	participants with severe hepatic impairment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 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 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 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.