drugset / Trial / NCT04382885
Cariprazine Pediatric ASD PK Study
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study will be a multi-center, open-label, parallel-group, multiple-dose study in up to 24 male and female participants aged 5 through 17 years, inclusive, with Autism Spectrum Disorder (ASD). The 24 participants will be enrolled into 1 of 4 cohorts (6 participants per cohort).
Timeline
- Start
- 2020-06-26
- Primary completion
- 2021-12-10
- Completion
- 2021-12-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cariprazine | Small molecule | 0.5 mg | Oral |
| Subject | Cariprazine | Small molecule | 0.75 mg | Oral |
| Subject | Cariprazine | Small molecule | 1.5 mg | Oral |
| Subject | Cariprazine | Small molecule | 3 mg | Oral |