NCT05126329

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

An Open-label Pharmacokinetic and Tolerability Study of Amcenestrant Given as a Single Dose in Female Participants With Mild and Moderate Hepatic Impairment, and in Matched Participants With Normal Hepatic Function

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Sanofi · Industry
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

The total study duration from screening period is approximately 41 days.

Conditions

• Hepatic Function Abnormal

Interventions

Type	Name	Description
DRUG	amcenestrant	tablet for oral use

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-05-16
• Completion: 2022-05-16
• First posted: 2021-11-19
• Last updated: 2025-09-22

Locations

3 sites across 2 countries: Germany, South Korea