Ignite Creation Date:
2024-05-06 @ 4:26 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04987658
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2021-07-26
Brief Title:
Phase 1 Study of OLZSAM in Pediatric Subjects With Bipolar I Disorder
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
A Phase 1 Multiple-dose Open-label Study to Evaluate the Safety Tolerability and Pharmacokinetics of OLZSAM in Pediatric Subjects 10-12 Years Old With Bipolar I Disorder
Status:
COMPLETED
Status Verified Date:
2023-11
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:
To evaluate the safety tolerability and pharmacokinetics of olanzapine and samidorphan in clinically stable pediatric subjects 10 to 12 years old with Bipolar I disorder following oral administration of multiple ascending doses of OLZSAM
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None