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

NCT00936871

Last updated date
Study Location
Pfizer Investigational Site
Bruxelles, , 1070, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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 CenterPfizer
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