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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: July 7, 2009
Last updated: September 1, 2010
Last verified: September 2010

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.

Condition Intervention Phase
Healthy Volunteers
Drug: Lersivirine
Drug: Placebo
Drug: Lersivirine (if necessary)
Drug: Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • (Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • (Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • To assess the single dose pharmacokinetics of lersivirine. [ Time Frame: 1 - 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Experimental: Part B
Thorough QTc
Drug: Lersivirine
Lersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results)
Drug: Placebo
Placebo single dose
Drug: Moxifloxacin
Moxifloxacin 400 mg single dose


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00936871

Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00936871     History of Changes
Other Study ID Numbers: A5271032
Study First Received: July 7, 2009
Last Updated: September 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
lersivirine QT QTc ECG HIV NNRTI

Additional relevant MeSH terms:
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on April 20, 2014