drugset / Trial / NCT05790304
Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects
Non-randomizedParallel-groupOpen-labelOther
Summary
This will be a Phase I, multicentre, single-dose, non-randomized, open-label, parallel-group study to examine the PK, safety, and tolerability of camizestrant 75 mg in post-menopausal female participants with moderate or severe hepatic impairment compared with post-menopausal female participants with normal hepatic function. Participants will be enrolled within the following groups based on their CP classification score as determined at screening: * Group 1: Matched-control healthy participants with normal hepatic function. * Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). * Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
Timeline
- Start
- 2023-02-20
- Primary completion
- 2024-02-22
- Completion
- 2024-02-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camizestrant | Other / unclassified | 75 mg | Oral |
Indications
No indication recorded.