drugset / Trial / NCT04987658
Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder
Non-randomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2021-07-22
- Primary completion
- 2023-08-11
- Completion
- 2023-08-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olanzapine | Small molecule | 10 mg | Oral |
| Subject | Samidorphan | Small molecule | 5 mg | Oral |
| Subject | Samidorphan | Small molecule | 10 mg | Oral |