Status:
COMPLETED
The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study has been designed to investigate the effect of lersivirine on the QT/QTc interval in order to help establish the safety profile of lersivirine.
Eligibility Criteria
Inclusion
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive, (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, normal 12-lead ECG and clinical laboratory tests)
Exclusion
- History of risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction).
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day
- Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00936871
Start Date
January 1 2010
End Date
March 1 2010
Last Update
September 6 2010
Active Locations (1)
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1
Pfizer Investigational Site
Brussels, Belgium, 1070