A Phase 1, Open-Label, Drug-Drug Interaction Study to Determine the Effect of Repeated Dose Lurasidone 120 mg Administration on the Pharmacokinetics of Orally Administered Digoxin 0.25 mg in Patients With Schizophrenia or Schizoaffective Disorder.

Sumitomo Pharma America, Inc.1 site in 1 country24 target enrollmentSeptember 2008

ConditionsSchizophrenia

DrugsLurasidone

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: Sumitomo Pharma America, Inc.
Enrollment: 24
Locations: 1
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the pharmacokinetic profile of digoxin when administered alone and when administered with repeated dose of lurasidone 120mg.

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

October 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sumitomo Pharma America, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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 28 days prior to study drug administration