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

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.

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Key information

Conditions

Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

California Clinical Trials, Glendale, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lurasidone HCl

Drug

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Feb 24, 2010
Registry last updated: Sep 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed