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

Phase 1

Completed

• Conditions: Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

• Registration Number: NCT01074632
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2010-02-23
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-06
• Last Update Posted: 2011-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

California Clinical Trials; 🇺🇸 Glendale, California, United States

Clinical Research Institute; 🇺🇸 Wichita, Kansas, United States