Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01493726
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2011-12-12
Brief Title:
A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
A Phase 1 Randomized Double-blind Placebo-controlled Multiple-dose Study to Evaluate the Safety Tolerability and Pharmacokinetics of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
Status:
COMPLETED
Status Verified Date:
2018-08
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 determine the pharmacokinetics PK safety and tolerability of ALKS 9072 also known as ALKS 9070 after 4 monthly doses in adults with chronic stable schizophrenia
Detailed Description:
Three active treatment groups and a placebo group are planned Randomization will be sequential by dose level across the sites with placebo assignments randomly inserted Each subjects participation will be approximately 8 months including screening treatment period and a 3-month follow-up period
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