Study Evaluating the Effects of MOA-728 on Cardiac Repolarization in Healthy Subjects
Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00434395
Collaborator
(none)
1
7
Study Details
Study Description
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 |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
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
:
Mar 1, 2007
Actual Study Completion Date
:
Oct 1, 2007
Outcome Measures
Primary Outcome Measures
- Cardiac repolarization will be assessed by the QTc interval in healthy subjects. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Phoenix | Arizona | United States | 85044 |
Sponsors and Collaborators
- Bausch Health Americas, Inc.
Investigators
- Study Director: Jeff Cohn, Bausch Health Americas, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00434395
Other Study ID Numbers:
- 3200L2-104
First Posted:
Feb 13, 2007
Last Update Posted:
Nov 25, 2019
Last Verified:
Nov 1, 2019