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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
Contact
1-800-718-1021
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.

NCT00936871
Pfizer
Completed
The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects

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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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
United States
 
NCT00936871
A5271032
No
Not Provided
Not Provided
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

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1-800-718-1021

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