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Trial record 1 of 1 for:    NCT00936871
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The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00936871
Recruitment Status : Completed
First Posted : July 10, 2009
Last Update Posted : September 6, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE July 7, 2009
First Posted Date  ICMJE July 10, 2009
Last Update Posted Date September 6, 2010
Study Start Date  ICMJE January 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2009)
  • (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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 8, 2009)
66
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00936871
Other Study ID Numbers  ICMJE A5271032
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2010

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