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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01074632
First received: February 23, 2010
Last updated: September 6, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
 Drug: Lurasidone HCl
 Phase 1

Study Type: Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Sunovion:

Enrollment: 26
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074632

Locations
United States, California
California Clinical Trials
Glendale, California, United States, 91206
United States, Kansas
Clinical Research Institute
Wichita, Kansas, United States, 67207
Sponsors and Collaborators
Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01074632     History of Changes
Other Study ID Numbers: D1050267
Study First Received: February 23, 2010
Last Updated: September 6, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013