NCT06911788

A Study to Learn How a Tablet Compared With an IV Infusion of the Study Medicine Called Vepdegestrant is Taken up Into the Blood in Healthy Adults

A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD, SINGLE-DOSE, CROSS-OVER STUDY TO ESTIMATE THE ABSOLUTE BIOAVAILABILITY OF VEPDEGESTRANT (ARV-471, PF-07850327) FOLLOWING ORAL AND INTRAVENOUS DOSING OF THE DRUG TO HEALTHY PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to learn how much of the study medicine called Vepdegestrant will reach the bloodstream when given orally compared to given intravenously. This study is seeking participants who: * are healthy males and healthy females who cannot have children. * are 18 years or older. * are 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). In Period 1, all participants will receive one dose of Vepdegestrant by IV. In Period 2, all participants will receive one dose of Vepdegestrant by mouth following a high-fat breakfast. The levels of Vepdegestrant in Period 1 will be compared to the levels of Vepdegestrant in Period 2 and the bioavailablility of the oral formulation of Vepdegestrant will be determined. The study duration is 22 days and includes two periods. Participants will stay in the clinical research unit for 9 days (8 nights) during each period. 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	Vepdegestrant (Reference)	Participants will receive a single intravenous (IV) dose of Vepdegestrant on Period 1 Day 1
DRUG	Vepdegestrant (Test)	Participants will receive a 200 mg single oral dose of Vepdegestrant tablet formulation on Period 2 Day 1

Timeline

• Start date: 2025-04-03
• Primary completion: 2025-05-23
• Completion: 2025-06-13
• First posted: 2025-04-04
• Last updated: 2025-06-29

Locations

2 sites across 1 country: Netherlands