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Completed

NCT Number: NCT00936871

The Effect 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lersivirine

Drug

Lersivirine 2400 mg single dose

Placebo

Drug

Placebo single dose

Lersivirine (if necessary)

Drug

Lersivirine 2100 mg single dose (if necessary)

moxifloxacin

Drug

Moxifloxacin 400 mg single dose

Primary outcomes

  1. (Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.

    Time frame: 1 day

  2. (Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo.

    Time frame: 3 days

Secondary outcomes

  1. 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.

    Time frame: 1 day

  2. To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.

    Time frame: 1 day

  3. To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine.

    Time frame: 1 day

  4. To assess the single dose pharmacokinetics of lersivirine.

    Time frame: 1 - 2 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 10, 2009
Registry last updated
Sep 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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