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A Study to Understand the Effects of Carbamazepine on How Vepdegestrant is Processed in Healthy Participants

NCT06005688 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-01-16

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

DRUG

Vepdegestrant

Participants will receive a single dose of Vepdegestrant by mouth in Period 1 and Period 2, with a washout period of at least 20 days between two doses of Vepdegestrant.

DRUG

Carbamazepine

Participants will receive Carbamazepine by mouth once a day for 19 days in Period 2.

Sponsors & Collaborators

  • Arvinas Estrogen Receptor, Inc.

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-18
Primary Completion
2023-10-11
Completion
2023-11-21

Countries

  • Belgium

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06005688 on ClinicalTrials.gov