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NCT Number: NCT07231991

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vepdegestrant

Drug

Vepdegestrant administered as a single oral 200 mg dose

Other names: ARV-471, PF-07850327

Primary outcomes

  1. 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

  2. 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

    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 outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events

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

  2. Number of Participants With Clinically Significant Clinical Laboratory Abnormalities

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

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

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

  4. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

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

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Arvinas Estrogen Receptor, Inc.

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 17, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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