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Digoxin Drug-Drug Interaction With Lurasidone HCl

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082289
First Posted: March 8, 2010
Last Update Posted: September 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunovion
  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: 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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01082289     History of Changes
Other Study ID Numbers: D1050279
First Submitted: March 5, 2010
First Posted: March 8, 2010
Last Update Posted: September 8, 2011
Last Verified: September 2011

Keywords provided by Sunovion:
Lurasidone
Schizophrenia
Latuda

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Digoxin
Lurasidone Hydrochloride
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents