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

This study has been completed.
Information provided by (Responsible Party):
Sunovion Identifier:
First received: February 23, 2010
Last updated: September 6, 2011
Last verified: September 2011
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:

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)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01074632

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
  More Information

Responsible Party: Sunovion 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 Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on October 21, 2016