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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

July 7, 2009
September 1, 2010
January 2010
March 2010   (final data collection date for primary outcome measure)
  • (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 ]
Same as current
Complete list of historical versions of study NCT00936871 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Healthy Volunteers
  • 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)
  • Drug: Moxifloxacin
    Moxifloxacin 400 mg single dose
  • Experimental: Part A
    Lersivirine Tolerability
    Interventions:
    • Drug: Lersivirine
    • Drug: Placebo
    • Drug: Lersivirine (if necessary)
  • Experimental: Part B
    Thorough QTc
    Interventions:
    • Drug: Lersivirine
    • Drug: Placebo
    • Drug: Moxifloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00936871
A5271032
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP