Actively Recruiting
A Study to Learn How the Body Processes the Study Medicine Called Vepdegestrant in People With Loss of Liver Function
Led by Pfizer · Updated on 2026-04-03
24
Participants Needed
4
Research Sites
57 weeks
Total Duration
On this page
Sponsors
P
Pfizer
Lead Sponsor
A
Arvinas Estrogen Receptor, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study to Learn How the Body Processes the Study Medicine Called Vepdegestrant in People With Loss of Liver Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants of non-childbearing potential, or male participants between 18 and 70 years old
- Body mass index between 17.5 and 38 kg/m2 and body weight over 50 kg (110 pounds)
- Normal liver function group: overtly healthy based on medical history, physical exam, lab tests, vital signs, and ECG
- Hepatic impairment groups: meet criteria for moderate (Class B) or severe (Class C) liver impairment by modified Child-Pugh Classification
- Hepatic impairment groups: stable liver impairment with no significant change in disease status in the 28 days before screening
You will not qualify if you...
- Any condition that could affect drug absorption
- Use of prohibited prior or current medications
- Normal liver function group: history or evidence of significant blood, kidney, hormone, lung, digestive, heart, liver, psychiatric, neurological, or allergic diseases (except untreated, asymptomatic seasonal allergies)
- Hepatic impairment groups: diagnosis of liver dysfunction caused by any acute ongoing liver cell damage documented by medical history, physical exam, biopsy, ultrasound, CT, or MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33172
Actively Recruiting
2
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States, 33016
Actively Recruiting
3
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
4
Genesis Clinical Research, LLC
Tampa, Florida, United States, 33603
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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