Cariprazine Pediatric ASD PK Study
NCT04382885 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2022-04-12
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).
Conditions
Interventions
- DRUG
-
Cariprazine
Oral Solution
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ALLERGAN INC. · Allergan
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-26
- Primary Completion
- 2021-12-10
- Completion
- 2021-12-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
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