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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00936871
First received: July 7, 2009
Last updated: September 1, 2010
Last verified: September 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00936871

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov 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:
Moxifloxacin
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

ClinicalTrials.gov processed this record on May 19, 2013