Trials / Completed
CompletedNCT04987658
Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder
A Phase 1, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OLZ/SAM in Pediatric Subjects (10-12 Years Old) With Bipolar I Disorder
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 10 Years – 12 Years
- Healthy volunteers
- Not accepted
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 OLZ/SAM
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OLZ/SAM | Olanzapine and Samidorphan taken once daily over a max period of 21 days |
Timeline
- Start date
- 2021-07-22
- Primary completion
- 2023-08-11
- Completion
- 2023-08-11
- First posted
- 2021-08-03
- Last updated
- 2023-11-22
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04987658. Inclusion in this directory is not an endorsement.