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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Lersivirine; Drug: Placebo; Drug: Lersivirine (if necessary); Drug: Moxifloxacin

• Registration Number: NCT00936871
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-10
• Study Start: 2010-01
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Disposition First Submitted: 2010-03-26
• Disposition First Submitted QC: 2010-03-26
• Disposition First Posted: 2010-03-30
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-01
• Last Update Posted: 2010-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A	Placebo	Lersivirine Tolerability
Part A	Lersivirine (if necessary)	Lersivirine Tolerability
Part B	Placebo	Thorough QTc
Part B	Moxifloxacin	Thorough QTc
Part A	Lersivirine	Lersivirine Tolerability
Part B	Lersivirine	Thorough QTc

Primary Outcome Measures

Name	Time	Method
(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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium