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

Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074632
• Other study ID #: D1050267
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2010
• Last updated: September 6, 2011
• Start date: May 2009
• Est. completion date: September 2009

Study information

• Verified date: September 2011
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia
• Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

Intervention

Drug:
• Lurasidone HCl

Locations

Country	Name	City	State
United States	California Clinical Trials	Glendale	California
United States	Clinical Research Institute	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States,