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NCT01082289 Clinical Trial

Digoxin Drug-Drug Interaction With Lurasidone HCl

Schizophrenia Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01082289
Other study ID # D1050279
Secondary ID
Status Completed
Phase Phase 1
First received March 5, 2010
Last updated September 6, 2011
Start date September 2008
Est. completion date October 2008

Study information
Verified date September 2011
Source Sunovion
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment

Related Conditions & MeSH terms

Intervention

Drug:
• Lurasidone

Locations
Country Name City State
United States California Clinical Trials Culver City California

Sponsors (1)
Lead Sponsor Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

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