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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 22, 2014