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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01074632
First Posted: February 24, 2010
Last Update Posted: September 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunovion
  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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01074632     History of Changes
Other Study ID Numbers: D1050267
First Submitted: February 23, 2010
First Posted: February 24, 2010
Last Update Posted: September 8, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Schizophrenia
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