NCT05790304

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

A Phase I, Single Dose, Non-Randomised, Multicentre, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Camizestrant in Post Menopausal Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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).

Detailed description

This will be an open-label, non-randomized, multicentre, parallel-group, single-dose study to investigate the PK, safety, and tolerability of camizestrant 75 mg administered orally to post-menopausal female participants with moderate or severe hepatic impairment compared to control post-menopausal female participants with normal hepatic function. A total of approximately 14 participants with hepatic impairment (8 participants with moderate impairment and 6 participants with severe impairment per CP classification) and 8 to 14 matched-control healthy participants with normal hepatic function are planned to be enrolled, with the goal of having approximately 8 participants with moderate impairment and approximately 6 participants with severe impairment and sufficient matching participants with normal hepatic function complete the study. All participants will receive a single oral dose of 75 mg camizestrant on Day 1 following an overnight fast. Study intervention will be administered orally with approximately 240 mL of water. Child-Pugh scoring, detailed in Table 3, will be used to determine the level of hepatic impairment. Participants will be enrolled into 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).

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Camizestrant	Camizestrant 75 mg tablets. Experimental drug.

Timeline

• Start date: 2023-02-20
• Primary completion: 2024-02-22
• Completion: 2024-02-22
• First posted: 2023-03-30
• Last updated: 2025-03-25

Locations

4 sites across 3 countries: United States, Bulgaria, Slovakia

Regulatory

• FDA-regulated drug study