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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Lersivirine; Drug: Placebo; Drug: Lersivirine (if necessary); Drug: Lersivirine; Drug: Moxifloxacin

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A; Lersivirine Tolerability	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)
Experimental: Part B; Thorough QTc	Drug: Lersivirine; Lersivirine 2400 mg single dose; Drug: Placebo; Placebo single dose; Drug: Lersivirine; Lersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results); Drug: Moxifloxacin; Moxifloxacin 400 mg single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (Estimate): July 10, 2009

Study Record Updates

• Last Update Posted (Estimate): September 6, 2010
• Last Update Submitted That Met QC Criteria: September 1, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: lersivirine QT QTc ECG HIV NNRTI
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: A5271032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No