drugset / Trial / NCT05126329
Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic Function
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
Outcome
Outcome not reported
Stopped (Business): “Sponsor decision to prematurely stop the study, not linked to any safety concern”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amcenestrant | Other / unclassified | 200 mg | Oral |