drugset / Trial / NCT05790304

Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects

NCT05790304

Phase 1 Completed 22 enrolled AstraZeneca
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

EvaluationDrugModalityDoseRoute
Subject Camizestrant Other / unclassified 75 mg Oral

Indications

No indication recorded.