What this study is
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.
What's being tested
- vepdegestrant
Intervention · DRUG
Vepdegestrant administered as a single oral 200 mg dose
Study details
- Official 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
- Sponsor
- Pfizer
- Conditions
- Healthy Participants
- Enrolling
- 24 people
- Starts
- 2025-11-18
- Est. completion
- 2026-12-23
- Design
- Open-label, non-randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex ALLHealthy volunteers Acceptedincluding but not limited to
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).
You can't join if
- Any condition possibly affecting drug absorption.
- Use of prohibited prior or concomitant medications.
Normal hepatic function group only
You may qualify if
- Overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and standard 12-lead ECGs.
You can't join if
- 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
You may qualify if
- 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 can't join if
- -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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openClinical Pharmacology of Miami
Miami, Florida, United States
RecruitingFloridian Clinical Research, LLC
Miami Lakes, Florida, United States
RecruitingOrlando Clinical Research Center
Orlando, Florida, United States
RecruitingGenesis Clinical Research, LLC
Tampa, Florida, United States
Recruiting
Study team
Sponsor
Pfizer
Study ID C4891004
Study director
Pfizer CT.gov Call Center
Pfizer
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.