Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576765
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics Safety and Tolerability of AZD0780
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Single-Dose Non-Randomised Open-label Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics Safety and Tolerability of AZD0780
Status:
RECRUITING
Status Verified Date:
2024-09
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 study will evaluate the pharmacokinetics PK safety and tolerability of a single oral dose of AZD0780 with moderate and possibly mild hepatic impairment in comparison to a matched healthy control group
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 AZD0780 dose 1 administered orally to male and female participants females of non-childbearing potential with moderate hepatic impairment and mild hepatic impairment optional compared with male and female participants females of non-childbearing potential with normal hepatic function
Participants will be enrolled within the following groups based on their Child Pugh classification score as determined at screening
Group 1 Participants with moderate hepatic impairment Child Pugh Class B score of 7 to 9
Group 2 Participants with normal hepatic function demographically matched by sex age and body mass index BMI to the impaired participants
Group 3 optional Participants with mild hepatic impairment Child Pugh Class A score of 5 or 6
Participants will be enrolled within the following groups based on their Child Pugh classification score as determined at screening
Group 1 Participants with moderate hepatic impairment Child Pugh Class B score of 7 to 9
Group 2 Participants with normal hepatic function demographically matched by sex age and body mass index BMI to the impaired participants
Group 3 optional Participants with mild hepatic impairment Child Pugh Class A score of 5 or 6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None