The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects
NCT00936871
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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)
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects | |||
Official Title ICMJE | A Phase 1, Randomized, Single Dose, Placebo And Active Controlled, 3-Way Crossover Study To Evaluate The Effect Of A Single Oral Dose Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Participant) Primary Purpose: Treatment | |||
Condition ICMJE | Healthy Volunteers | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 66 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2010 | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00936871 | |||
Other Study ID Numbers ICMJE | A5271032 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | September 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |