- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01074632
Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl
September 6, 2011 updated by: Sunovion
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.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Glendale, California, United States, 91206
- California Clinical Trials
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Kansas
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Wichita, Kansas, United States, 67207
- Clinical Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
February 23, 2010
First Submitted That Met QC Criteria
February 23, 2010
First Posted (Estimate)
February 24, 2010
Study Record Updates
Last Update Posted (Estimate)
September 8, 2011
Last Update Submitted That Met QC Criteria
September 6, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Psychotic Disorders
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Adrenergic alpha-Antagonists
- Adrenergic alpha-2 Receptor Antagonists
- Lurasidone Hydrochloride
Other Study ID Numbers
- D1050267
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
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University of North Carolina, Chapel HillNorth Carolina Department of Health and Human ServicesRecruitingSchizophrenia | Schizoaffective Disorder | Schizophreniform Disorders | Unspecified or Other Psychotic DisordersUnited States
-
Centre for Addiction and Mental HealthUniversity of Maryland, Baltimore; National Institutes of Health (NIH); The Feinstein...CompletedSchizophrenia | Schizoaffective Disorder | Schizophreniform DisordersUnited States, Canada
-
University of North Carolina, Chapel HillNorth Carolina Department of Health and Human ServicesCompletedSchizophrenia | Schizoaffective Disorder | Schizophreniform Disorders | Unspecified Schizophrenia Spectrum and Other Psychotic DisorderUnited States
-
University College, LondonCompletedSchizophrenia | Schizoaffective Disorder | Delusional Disorder | Schizophreniform DisordersUnited Kingdom
-
Pakistan Institute of Living and LearningNot yet recruitingSchizophrenia | Schizoaffective Disorder | Psychosis | Schizophreniform Disorders
-
New York State Psychiatric InstituteTemple University; The Zucker Hillside Hospital; Feinstein Institutes for Medical...Not yet recruitingSchizophrenia | Schizoaffective Disorder | Delusional Disorder | Schizophreniform Disorders | Other Specified Schizophrenia Spectrum and Other Psychotic Disorder
-
Tangent DataStanley Medical Research Institute; MediStat Ltd.; PCI pharma services (formerly... and other collaboratorsUnknownSchizophrenia | Schizoaffective Disorder | Schizophreniform DisordersMoldova, Republic of
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Tangent DataStanley Medical Research InstituteCompletedSchizophrenia | Schizoaffective Disorder | Schizophreniform DisordersMoldova, Republic of
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Johnson & Johnson Pharmaceutical Research & Development...CompletedSchizophrenia | Schizoaffective Disorder | Schizophreniform Disorders
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Chonbuk National University HospitalCompletedSchizophrenia | Schizoaffective Disorder | Psychotic Disorder Not Otherwise Specified | Schizophreniform Disorders | Schizophrenia Spectrum DisordersKorea, Republic of
Clinical Trials on Lurasidone HCl
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SunovionCompleted
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Sumitomo Pharma (Suzhou) Co., Ltd.SunovionTerminatedBipolar I DepressionChina
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SunovionCompletedSchizophrenia | Schizoaffective DisorderUnited States
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SunovionCompletedSchizophreniaUnited States, Malaysia, Ukraine, India, Romania, Russian Federation, France
-
Sumitomo Pharma (Suzhou) Co., Ltd.Completed
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SunovionCompletedSchizophrenia | Schizoaffective DisorderUnited States, Israel, Chile, South Africa, Argentina, Brazil, Croatia, Thailand
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SunovionCompleted
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SunovionCompleted
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University of California, IrvineDainippon Sumitomo Pharma AmericaCompletedSchizophreniaUnited States
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NeuroRx, Inc.Prevail Infoworks, IncActive, not recruitingBipolar Depression | Suicidal Ideation and BehaviorUnited States