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

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00434395
First received: February 9, 2007
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: MOA-728
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Further study details as provided by Salix Pharmaceuticals:

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

Study Start Date: March 2007
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434395

Locations
United States, Arizona
Phoenix, Arizona, United States, 85044
Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
Study Director: Jeff Cohn Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00434395     History of Changes
Other Study ID Numbers: 3200L2-104
Study First Received: February 9, 2007
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013