An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder
Intra-Cellular Therapies, Inc.
Summary
Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.
Eligibility
- Age range
- 5–12 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female patients between 5 to less than 13 years of age * Primary clinical diagnosis of ASD with symptoms of irritability * ABC-I subscale score of ≥12 at Screening * CGI-S score of ≥3 at Screening * Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening * Ability to swallow capsules Exclusion Criteria: * Has a primary psychiatric diagnosis other than ASD * Reports suicidal ideation (Type 3, 4 or 5 on the Baseline/Screening version of the C-SSRS) within 6 months prior to Screenin…
Interventions
- DrugLumateperone 10.5 mg capsule
Lumateperone 10.5 mg capsule, oral administration
- DrugLumateperone 21 mg capsule
Lumateperone 21 mg capsule, oral administration
- DrugLumateperone 5 mg ODT
Lumateperone 5 mg ODT, oral administration
- DrugLumateperone 10.5 mg ODT
Lumateperone 10.5 mg ODT, oral administration
- DrugLumateperone 15.5 mg ODT
Lumateperone 5 mg ODT + 10.5 mg ODT, oral administration
- DrugLumateperone 21 mg ODT
Lumateperone 21 mg ODT, oral administration
Locations (8)
- Clinical Site 6Miami, Florida
- Clinical Site 7Orlando, Florida
- Clinical Site 1Atlanta, Georgia
- Clinical Site 2Decatur, Georgia
- Clinical Site 3Savannah, Georgia
- Clinical Site 4Saint Charles, Missouri