Ignite Creation Date:
2024-05-06 @ 8:42 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02804568
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2016-06-15
Brief Title:
A Phase 1 Safety Study in Adults With Schizophrenia
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
A Multiple-dose Open-label Study to Evaluate the Pharmacokinetics Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2016-09
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 safety tolerability and pharmacokinetics PK of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831
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