- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00434395
Study Evaluating the Effects of MOA-728 on Cardiac Repolarization in Healthy Subjects
November 21, 2019 updated by: Bausch Health Americas, Inc.
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
The purpose of the study is to assess the effects of MOA-728 on cardiac repolarization in healthy subjects.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85044
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Cardiac repolarization will be assessed by the QTc interval in healthy subjects.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jeff Cohn, Bausch Health Americas, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
February 9, 2007
First Submitted That Met QC Criteria
February 12, 2007
First Posted (Estimate)
February 13, 2007
Study Record Updates
Last Update Posted (Actual)
November 25, 2019
Last Update Submitted That Met QC Criteria
November 21, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 3200L2-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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