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.

Sumitomo Pharma America, Inc.2 sites in 1 country26 target enrollmentMay 2009

ConditionsSchizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

DrugsLurasidone HCl

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
Sponsor: Sumitomo Pharma America, Inc.
Enrollment: 26
Locations: 2
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

September 2009

Last Updated

14 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Sumitomo Pharma America, Inc.

Responsible Party

Sponsor

Eligibility 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