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New treatment option for Healthy Participants
Official title A Study to Learn How the Body Processes the Study Medicine Called Vepdegestrant in People With Loss of Liver Function
ClinicalTrials.gov ID: NCT07231991
What this study is testing
What is vepdegestrant?
vepdegestrant is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy participants.
Also referred to as ARV-471, PF-07850327.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
- Satisfy the criteria for Class B (Group 2: moderate hepatic impairment) or C (Group 3: severe hepatic impairment) of the modified Child-Pugh...
- Stable hepatic impairment, defined as no clinically significant change in disease status within the last 28 days prior to the screening visit, as...
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Miami Lakes, Florida, United States; Orlando, Florida, United States; Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.