Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919069
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-06-16
Brief Title:
A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK Safety and Tolerability of AZD2693
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Single Dose Non-Randomised Open-Label Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics Safety and Tolerability of AZD2693
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment
Detailed Description:
This is a Phase I multicentre single-dose non-randomised open-label parallel-group study to examine the PK safety and tolerability of AZD2693 administered as an subcutaneous injection in male and female participants with mild moderate or severe hepatic impairment compared with male and female participants with normal hepatic function as control Eight participants with mild impairment CP Class A 8 participants with moderate impairment CP Class B 8 participants with severe impairment CP Class C and 8 to12 participants with normal hepatic function matched on a group level regarding age body weight and sex to the impaired participants are planned for study intervention with the goal of having at least 6 evaluable participants within each group Study participants who self-withdraw after study intervention may be replaced to ensure that at least 6 participants per group are evaluable and complete the study per protocol An evaluable participant is defined as having adequate plasma PK profile to meet the primary study objective Child-Pugh scoring detailed in Table 2 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 Participants with mild hepatic impairment CP Class A score of 5 or 6
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
Group 4 Participants with normal hepatic function
Study Arms and Duration
Planned screening duration per participant up to 4 weeks
Planned study duration screening to follow-up per participant up to 16 weeks
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
Group 4 Participants with normal hepatic function
Study Arms and Duration
Planned screening duration per participant up to 4 weeks
Planned study duration screening to follow-up per participant up to 16 weeks
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