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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Lurasidone Hydrochloride

Criteria

Inclusion Criteria:

• Male and female 18 to 65 years of age

• BMI >= 19.5 and <= 37 kg/m2

• No clinically relevant abnormal laboratory values

Exclusion Criteria:

• History or presence of renal or hepatic insufficiency

• Participated in a clinical trial in the past 30 days

• Use of con meds that prolong the QT/QTc taken within 14 days prior to study drug administration