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

Sumitomo Pharma

Status and phase: Completed; Phase 1

Conditions: Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

Treatments: Drug: Lurasidone HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01074632

D1050267

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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