NCT07231991 · Pfizer
A Study to Learn How the Body Processes the Study Medicine Called Vepdegestrant in People With Loss of Liver Function
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Miami, Florida
- Miami Lakes, Florida
- Orlando, Florida
- Tampa, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2026 · Source of record for eligibility and locations