Back to resultsEffect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl
Primary Purpose
Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lurasidone HCl
Sponsored by
About this trial
This is an interventional trial for Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
Eligibility 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
Sites / Locations
- California Clinical Trials
- Clinical Research Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01074632
First Posted
February 23, 2010
Last Updated
September 6, 2011
Sponsor
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01074632
Brief Title
Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
7. Study Design
Study Phase
Phase 1
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lurasidone HCl
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
California Clinical Trials
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Clinical Research Institute
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl
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