NCT05652660

A Study to Understand the Effect of a Study Medicine Called ARV-471 on Rosuvastatin in Healthy Adults

AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY TO EVALUATE THE EFFECT OF A SINGLE ORAL DOSE OF ARV-471 (PF-07850327) ON THE PHARMACOKINETICS OF ROSUVASTATIN IN HEALTHY PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to understand if ARV-471 affects how a BCRP substrate (rosuvastatin) gets into the body in healthy adults. All participants in this study will receive one dose of rosuvastatin alone by mouth in Period 1. In Period 2, everyone will receive one dose of ARV-471 by mouth 90 min before one dose of rosuvastatin by mouth. The levels of rosuvastatin in Period 1 will be compared to the levels of rosuvastatin in Period 2 to determine if ARV-471 affects how rosuvastatin gets into the body differently in healthy adults. All participants will stay at the study clinic for 10 days and 9 nights.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ARV-471	Experimental
DRUG	Rosuvastatin	Probe substrate

Timeline

• Start date: 2022-12-09
• Primary completion: 2023-02-09
• Completion: 2023-03-06
• First posted: 2022-12-15
• Last updated: 2024-07-26
• Results posted: 2024-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study