Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl
Phase 1
Completed
- Conditions
- Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
- Registration Number
- NCT01074632
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- Male and female 18 to 65 years of age
- BMI >= 19.5 and <= 37 kg/m2
- No clinically relevant abnormal laboratory values
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Clinical Research Institute
🇺🇸Wichita, Kansas, United States
California Clinical Trials
🇺🇸Glendale, California, United States