Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-13 @ 11:08 AM
Study NCT ID:
NCT02508506
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function
Sponsor:
Alkermes, Inc.
Organization:
Study Overview
Official Title:
A Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of ALKS5461 in Subjects With Renal 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 renal function on the pharmacokinetics and safety of ALKS 5461.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: