CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
ARV-471 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05652660
NCT05652660Phase 1Completed

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

Pfizer·interventional·Posted Dec 15, 2022·Updated Jul 26, 2024

In Brief

A Phase 1 clinical trial evaluating ARV-471 and Rosuvastatin for Healthy. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedDec 15, 2022
Enrollment StartDec 9, 2022
Primary CompletionFeb 9, 2023
Study CompletionMar 6, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.5 years ago

Interventions

ARV-471drug

Experimental

Rosuvastatindrug

Probe substrate