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drugset / Trial / NCT05538312

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

NCT05538312 ↗

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

Summary

The purpose of this study is to understand if a strong CYP3A4 inhibitor (itraconazole) affects how ARV-471 is processed and eliminated in healthy adults. All participants in this study will receive one dose of ARV-471 alone by mouth in Period 1. In Period 2, everyone will receive itraconazole by mouth once a day for multiple days. Participants will also receive one dose of ARV-471 by mouth. The levels of ARV-471 in Period 1 will be compared to the levels of ARV-471 in Period 2 to determine if the CYP3A4 inhibitor affects how ARV-471 is processed differently in healthy adults.

Timeline

Start
2023-02-23
Primary completion
2023-04-24
Completion
2023-05-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule — Oral
Subject vepdegestrant Other / unclassified — Oral

Indications

No indication recorded.