Recruiting
Phase 1

Vepdegestrant

Sponsor:

Pfizer

Code:

NCT07231991

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

vepdegestrant

Study Details

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

Study ID

NCT07231991

Start date

Nov 18, 2025

Status verified date

Mar, 2026

Completion date

Dec 23, 2026

Anticipated

Primary completion date

Dec 4, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion criteria including but not limited to:

  • 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 including but not limited to:

  • 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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Group 1

participants with normal hepatic function

experimental: Group 2

participants with moderate hepatic impairment

experimental: Group 3

participants with severe hepatic impairment

Interventions

vepdegestrant

Vepdegestrant administered as a single oral 200 mg dose

Primary outcome measure

  • Maximum observed concentration (Cmax) for vepdegestrant [ Time Frame: 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 [ Time Frame: Pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, and 216 hours post dose ]

Central Contacts and Locations

Central contacts

Locations

Clinical Pharmacology of Miami

Recruiting

Miami, Florida, United States, 33172

Floridian Clinical Research, LLC

Recruiting

Miami Lakes, Florida, United States, 33016

Orlando Clinical Research Center

Recruiting

Orlando, Florida, United States, 32809

Genesis Clinical Research, LLC

Recruiting

Tampa, Florida, United States, 33603

More Information

Sponsor

Pfizer

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-04-03.