Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867941
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2021-04-28
Brief Title:
A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics PK of ACP-196
Sponsor:
Acerta Pharma BV
Organization:
Acerta Pharma BV
Study Overview
Official Title:
A 2-Part Open-Label Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of ACP-196
Status:
COMPLETED
Status Verified Date:
2021-04
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:
The study will evaluate the influence of hepatic insufficiency on the PK of ACP-196
Detailed Description:
This is a 2-part study Part 1 of the study will compare the PK of ACP-196 in participants with mild hepatic insufficiency a score of 5 to 6 on the Child-Pugh scale and moderate hepatic insufficiency a score of 7 to 9 on the Child-Pugh scale to healthy mean matched control participants for age and weight Part 2 of the study if it is conducted will compare the PK of ACP-196 in participants with severe hepatic insufficiency a score of 10 to 15 on the Child-Pugh scale to the healthy control participants from Part 1 In Part 1 6 participants with mild hepatic insufficiency 6 participants with moderate hepatic and 6 healthy control participants matched to the hepatic insufficiency groups according to mean age and mean weight will be enrolled In Part 2 if conducted 6 participants with severe hepatic insufficiency will be enrolled The control group of Part 1 will be used for Part 2 PK comparison Participants will be screened within 28 days before the dose Participants will be contacted approximately 14 days after the last dose of study drug administration to determine if any adverse event has occurred since the last dose of study drug
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