NCT06256510

A Study to Learn If the Study Medicine Called Vepdegestrant Changes How the Body Processes the Other Study Medicine Called Midazolam

AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY TO ESTIMATE THE EFFECT OF SINGLE AND MULTIPLE DOSES OF VEPDEGESTRANT (ARV-471, PF-07850327) ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM IN HEALTHY ADULT FEMALES OF NON-CHILDBEARING POTENTIAL.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to learn if the study medicine called Vepdegestrant changes how the body processes the other study medicine called Midazolam. This study is seeking participants who: * female who cannot have children. * are 18 years or older. * are overtly 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). All participants in this study will receive one dose of midazolam alone by mouth in Period 1. In Period 2, all participants will receive vepdegestrant by mouth once a day for 15 days. Participants will also receive one dose of midazolam by mouth on day 1 and day 15. The levels of midazolam in Period 1 will be compared to the levels of midazolam in Period 2 Day 1 and Day 15 to decide if vepdegestrant affects how midazolam is processed differently in healthy adults. The study duration is 22 days and includes two periods. Participants will stay in the clinical research unit through the end of period 2. 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

Type	Name	Description
DRUG	Midazolam	Participants will receive a single dose of Midazolam by mouth in Period 1 Day 1, and Period 2 Day 1 and Day 15
DRUG	Vepdegestrant	Participants will receive Vepdegestrant by mouth once a day for 15 days in Period 2.

Timeline

• Start date: 2024-02-08
• Primary completion: 2024-04-16
• Completion: 2024-05-13
• First posted: 2024-02-13
• Last updated: 2025-01-21

Locations

1 site across 1 country: Belgium