NCT06645938

A Study to Learn How Different Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood in Healthy Adults

A PHASE I, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 2-TREATMENT, 2-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY ADULT PARTICIPANTS TO ESTIMATE THE BIOAVAILABILITY OF AN VARIANT (HIGH HARDNESS) TABLET OF VEPDEGESTRANT (ARV-471, PF-07850327) RELATIVE TO THE REGISTRATIONAL TABLET

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to compare the amount vepdegestrant available from two different tablet formulations under fed conditions in healthy adult participants; 200 mg vepdegestrant alternative tablet formulation compared to 200 mg vepdegestrant standard tablet formulation. This study is seeking male or female participants of non-childbearing potential age who: * 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; and a total body weight of more than 45 kilograms (99 pounds). All participants will be put into groups to receive one of the 2 treatments in each period. This study will consist of 2 treatment sequences: * Sequence 1: Single 200 mg dose of vepdegestrant registrational tablet in Period 1, followed by a single 200 mg dose of vepdegestrant variant tablet in Period 2. * Sequence 2: Single 200 mg dose of vepdegestrant variant tablet in Period 1, followed by a single 200 mg dose of vepdegestrant registrational tablet in Period 2. Participants will be in the study for about 11 weeks.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	single dose of vepdegestrant as tablet formulation (Treatment A)	Single 200 mg dose of vepdegestrant registrational (200 mg strength) tablet.
DRUG	single dose of vepdegestrant as tablet formulation (Treatment B)	Single 200 mg dose of vepdegestrant variant (200 mg strength) tablet.

Timeline

• Start date: 2024-10-16
• Primary completion: 2025-02-20
• Completion: 2025-03-14
• First posted: 2024-10-17
• Last updated: 2025-05-25

Locations

1 site across 1 country: Belgium