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The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects


Trial Overview

StatusConditionSponsor/Collaborator(s)First ReceivedLast ChangedVerification Date
Completed Healthy Volunteers Pfizer Industry July 7, 2009 September 1, 2010 September 2010

Study TypeStudy DesignPhaseEnrollmentStart DateEnd Date
Interventional Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment Phase 1 66 January 2010 -

Locations

FacilityAddressContactPhoneEmailStatus
Pfizer Investigational Site Bruxelles 1070 Belgium - - - -

Intervention

TypeInterventionDescription
Drug Lersivirine Lersivirine 2400 mg single dose
Drug Placebo Placebo single dose
Drug Lersivirine (if necessary) Lersivirine 2100 mg single dose (if necessary)
Drug Lersivirine Lersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results)
Drug Placebo Placebo single dose
Drug Moxifloxacin Moxifloxacin 400 mg single dose

Outcome

TypeMeasureTime FrameSafety Issue
Primary (Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects. 1 day Yes
Primary (Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo. 3 days Yes
Secondary To determine study sensitivity by comparing the effect of moxifloxacin on QTc relative to time-matched placebo, at the historical moxifloxacin Tmax of 3 hours. 1 day Yes
Secondary To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects. 1 day Yes
Secondary To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine. 1 day No
Secondary To assess the single dose pharmacokinetics of lersivirine. 1 - 2 days No

Official Title

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

Eligibility

GenderMinimum AgeMaximum AgeHealthy Volunteers
Both - 55 Years Accepts Healthy Volunteers

Inclusion Criteria:

- 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 Criteria:

- 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.

References

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