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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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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

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 ]
  • (Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo. [ Time Frame: 3 days ]

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 ]
  • To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects. [ Time Frame: 1 day ]
  • To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine. [ Time Frame: 1 day ]
  • To assess the single dose pharmacokinetics of lersivirine. [ Time Frame: 1 - 2 days ]

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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

Keywords provided by Pfizer:
lersivirine QT QTc ECG HIV NNRTI

Additional relevant MeSH terms:
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on September 21, 2017