drugset / Trial / NCT06645938

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

NCT06645938

Phase 1 Completed 12 enrolled Pfizer Arvinas Estrogen Receptor, Inc. · collab
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2024-10-16
Primary completion
2025-02-20
Completion
2025-03-14

Drugs

EvaluationDrugModalityDoseRoute
Subject vepdegestrant Other / unclassified 200 mg

Indications

No indication recorded.