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Digoxin Drug-Drug Interaction With Lurasidone HCl

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01082289
First received: March 5, 2010
Last updated: September 6, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
 Drug: Lurasidone
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunovion:

Enrollment: 24
Study Start Date: September 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082289

Locations
United States, California
California Clinical Trials
Culver City, California, United States, 90232
Sponsors and Collaborators
Sunovion
Investigators
Principal Investigator: Marina Bussel, MD California Clinical Trials
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01082289     History of Changes
Other Study ID Numbers: D1050279
Study First Received: March 5, 2010
Last Updated: September 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Lurasidone
Schizophrenia
Latuda

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013