Conditions: Schizophrenia Autism
Keywords: Schizophrenia autism bipolar Lurasidone Latuda
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 105
Healthy volunteers: no

Brief summary:
This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric disorders.

Detailed description:
To characterize lurasidone PK profile following single and multiple oral doses of 20, 40,80, 120 or 160 mg/day lurasidone in the targeted pediatric/adolescent population (6-17 years old)with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder or other psychiatric disorders. Data from this study will be used to recommend pediatric doses that result in comparable exposures to those observed in currently approved adult doses of Latuda® (40, 80, 120 and 160 mg/day) in subsequent efficacy and safety studies.

Arms:
arm 1: Lurasidone 20, 40, 80, 120 or 160 mg/day

Interventions: intervention 1: Lurasidone
Intervention descriptions: intervention 1: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days

Protocol document: