Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388616
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-04-16
Brief Title:
Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics Safety and Tolerability of Balcinrenone
Sponsor:
AstraZeneca
Organization:
AstraZeneca
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 Balcinrenone
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group
Detailed Description:
This is an open-label non-randomised multicentre parallel-group single-dose study to examine the PK safety and tolerability of balcinrenone 50 mg administered orally to male and female participants with mild or moderate hepatic impairment compared with control participants with normal hepatic function Eight participants with mild impairment and 8 participants with moderate impairment per CP classification and 8 to 12 participants with normal hepatic function matched on a group level regarding age BMI and sex to the impaired groups are planned for study intervention All participants will receive a single dose of balcinrenone 50 mg on Day 1 following an overnight fast Study intervention will be administered orally with approximately 240 mL of water
Child-Pugh scoring 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 normal hepatic function matched on a group level regarding age BMI and sex to the impaired groups
Child-Pugh scoring 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 normal hepatic function matched on a group level regarding age BMI and sex to the impaired groups
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