Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl
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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 or disease
Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
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 Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male and female 18 to 65 years of age
BMI >= 19.5 and <= 37 kg/m2
No clinically relevant abnormal laboratory values
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