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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Lersivirine
* Drug: Placebo
* Drug: Lersivirine (if necessary)
* Drug: Lersivirine
* Drug: Placebo
* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>Lersivirine Tolerability | Drug: Lersivirine<br>* Lersivirine 2400 mg single dose<br>Drug: Placebo<br>* Placebo single dose<br>Drug: Lersivirine (if necessary)<br>* Lersivirine 2100 mg single dose (if necessary)<br>|
| Experimental: Part B<br>Thorough QTc | Drug: Lersivirine<br>* Lersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results)<br>Drug: Placebo<br>* Placebo single dose<br>Drug: Moxifloxacin<br>* Moxifloxacin 400 mg single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects. |  | 1 day | 
| (Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo. |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects. |  | 1 day | 
| To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine. |  | 1 day | 
| To assess the single dose pharmacokinetics of lersivirine. |  | 1 - 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lersivirine QT QTc ECG HIV NNRTI