drugset / Trial / NCT03292848
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
Phase 1
Completed
24 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S · collab
Non-randomizedCrossoverOpen-labelTreatment
Summary
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to \<13 years with CNS disorders.
Timeline
- Start
- 2017-10-10
- Primary completion
- 2018-05-21
- Completion
- 2018-05-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexpiprazole | Small molecule | 0.75 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 1.5 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 3 mg | Oral |