NCT01620060

Lurasidone Pediatric Pharmacokinetics Study

A Phase 1 Open-Label, Multicenter, Single and Multiple Ascending Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Lurasidone in Subjects 6 to 17 Years Old With Schizophrenia Spectrum, Bipolar Spectrum, Autistic Spectrum Disorder, or Other Psychiatric Disorders

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Autism

Interventions

Type	Name	Description
DRUG	Lurasidone	Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-06-15
• Last updated: 2016-04-08
• Results posted: 2014-07-31

Locations

10 sites across 1 country: United States