drugset / Trial / NCT05126329

Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic Function

NCT05126329

Phase 1 Terminated 13 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1, parallel, open-label, 3-arm study to investigate the pharmacokinetic (PK) parameters of amcenestrant in female participants aged 40 to 75 years with mild and moderate hepatic impairment, and in matched participants with normal hepatic function.

Timeline

Start
2021-11-15
Primary completion
2022-05-16
Completion
2022-05-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Amcenestrant Other / unclassified 200 mg Oral

Indications