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Study Evaluating the Effects of MOA-728 on Cardiac Repolarization in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00434395
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
The purpose of the study is to assess the effects of MOA-728 on cardiac repolarization in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: MOA-728 Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo- and Moxifloxacin (Open-Label)-Controlled, 4-Period Crossover Study of the Effects of a Single Dose of MOA-728 Infused Intravenously on Cardiac Repolarization in Healthy Subjects
Study Start Date : March 2007
Study Completion Date : October 2007



Primary Outcome Measures :
  1. Cardiac repolarization will be assessed by the QTc interval in healthy subjects.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Generally healthy subjects men or women aged 18-50

Exclusion Criteria:

  • Any significant clinically important disease
  • Family history of long QT syndrome and/or sudden cardiac death
  • Allergy to moxifloxacin or the quinolone class of antibiotics

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): NCT00434395


Locations
United States, Arizona
Phoenix, Arizona, United States, 85044
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.

Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00434395     History of Changes
Other Study ID Numbers: 3200L2-104
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011