NCT06275841

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

A PHASE 1, OPEN-LABEL, 2-PERIOD STUDY TO EVALUATE THE EFFECT OF MULTIPLE DOSES OF ESOMEPRAZOLE ON THE PHARMACOKINETICS OF SINGLE DOSE VEPDEGESTRANT (ARV-471, PF-07850327) UNDER THE FED CONDITION IN HEALTHY ADULT MALES AND HEALTHY ADULT FEMALES OF NONCHILDBEARING POTENTIAL

• 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 investigate the effect of multiple doses of a proton-pump inhibitor (PPI) esomeprazole on the PK of vepdegestrant under fed conditions in healthy adult participants. All participants in this study will receive one dose of vepdegestrant alone by mouth in Period 1. In Period 2, everyone will receive esomeprazole by mouth once a day for multiple 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 determine if the PPI affects how vepdegestrant is processed differently in healthy adults.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	vepdegestrant	experimental
DRUG	esomeprazole	Experimental treatment to assess an endpoint

Timeline

• Start date: 2024-02-23
• Primary completion: 2024-05-03
• Completion: 2024-05-24
• First posted: 2024-02-23
• Last updated: 2024-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study