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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01074632

Enrollment

Registered

2010-02-24

Start date

2009-05-31

Completion date

2009-09-30

Last updated

2011-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

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.

Interventions

DRUGLurasidone HCl

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026