Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575959
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems MK-0616-030
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Hepatic Impairment
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol LDL-C in a persons blood Enlicitide decanoate will be called enlicitide from this point forward
The purpose of this study is to learn what happens to enlicitide in a persons body over time a pharmacokinetic or PK study Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment HI- meaning the liver does not work properly and people who are in good health
This study will have 2 parts In Part 1 enlicitide will be given to people with moderate HI and people who are in good health After Part 1 researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health
The purpose of this study is to learn what happens to enlicitide in a persons body over time a pharmacokinetic or PK study Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment HI- meaning the liver does not work properly and people who are in good health
This study will have 2 parts In Part 1 enlicitide will be given to people with moderate HI and people who are in good health After Part 1 researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health
Detailed Description:
None
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