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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: Lersivirine; Drug: Moxifloxacin; Drug: Lersivirine (if necessary)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00936871

A5271032

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Part A

Experimental group

Description:

Lersivirine Tolerability

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Lersivirine

Drug: Lersivirine (if necessary)

Drug: Lersivirine

Part B

Experimental group

Description:

Thorough QTc

Treatment:

Drug: Moxifloxacin

Drug: Placebo

Drug: Placebo

Drug: Lersivirine

Drug: Lersivirine