A Study to Understand the Effects of Carbamazepine on How Vepdegestrant is Processed in Healthy Participants
Status:
Completed
Trial end date:
2023-11-21
Target enrollment:
Participant gender:
Summary
The purpose of this study is to understand if carbamazepine reacts with vepdegestrant and
affects how it is processed in the bodies of healthy participants.
This study is seeking participants who:
- are male, or female who cannot have children.
- are 18 years or older.
- are extremely healthy as decided by medical tests.
- have a body mass index (BMI) of 16 to 32 kilogram per meter squared.
- have a total body weight of more than 45 kilograms (99 pounds).
- can understand the study needs and provide a signed document to take part in the study.
All participants in this study will receive one dose of vepdegestrant alone by mouth in
Period 1. In Period 2, all participants will receive carbamazepine by mouth once a day for 19
days. Participants will also receive one dose of vepdegestrant by mouth.
The levels of vepdegestrant in Period 1 will be compared to the levels of vepdegestrant in
Period 2 to decide if carbamazepine affects how vepdegestrant is processed differently in
healthy adults.
The study duration is 27 days and includes two periods. Participants will stay in the
clinical research unit through the end of period 2. The participants may be allowed to leave
on Day 4 or at the end of Period 1 but must return at the study doctor's call to complete the
study. A follow-up visit for each participant takes place at 28 to 35 days after taking the
study medicine for the last time.