NCT01074632

Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl

A Phase 1, Open-Label Study to Determine the Effect of Calories and Fat Content on the Pharmacokinetics of Repeated Dose Lurasidone 120 mg in Subjects With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the effect of calorie and fat content on the pharmacokinetics of Lurasidone HCl in subjects with schizophrenia, schizoaffective disorder, or schizophreniform disorder.

Conditions

• Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

Interventions

Type	Name	Description
DRUG	Lurasidone HCl

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2010-02-24
• Last updated: 2011-09-08

Locations

2 sites across 1 country: United States