Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
Study NCT ID:
NCT05919069
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2023-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693
Sponsor:
AstraZeneca
Organization:
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:
COMPLETED
Status Verified Date:
2024-11
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?: