Ignite Creation Date:
2024-05-06 @ 4:06 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02452801
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2015-05-21
Brief Title:
Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
A Phase 1 Study of the Pharmacokinetics Safety and Tolerability of ALKS 5461 in Subjects With Hepatic Impairment
Status:
COMPLETED
Status Verified Date:
2016-02
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 effect of various degrees of hepatic function on the pharmacokinetics and safety of ALKS 5461
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