Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05790304
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2023-01-25
Brief Title:
Study to Investigate Hepatic Impairment on PK Safety Tolerability of Camizestrant in Post-Menopausal Female Subjects
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-502277-41-00 | OTHER | EMA- CTIS | None |