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Study Evaluating The Effect of Bosutinib (SKI-606) On Cardiac Repolarization (Rhythms Of The Heart)

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Tacoma, Washington, 98418 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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determined by the investigator, including physical examination, laboratory test results,
and medical history.

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

determined by the investigator, including physical examination, laboratory test results,
and medical history.

NCT00914121
Pfizer
Completed
Study Evaluating The Effect of Bosutinib (SKI-606) On Cardiac Repolarization (Rhythms Of The Heart)

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Study Evaluating The Effect of Bosutinib (SKI-606) On Cardiac Repolarization (Rhythms Of The Heart)
A Single Dose, Crossover, Placebo- and Moxifloxacin- Controlled Study of the Effects of Bosutinib on Cardiac Repolarization in Healthy Adult Subjects
The purpose of this study is to examine the effect of SKI-606 on rhythms of the heart (cardiac repolarization)
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy Subjects
  • Drug: SKI-606
    Other Name: Bosutinib
  • Drug: Placebo
  • Drug: Moxifloxacin
  • Experimental: 1
    SKI-606 alone
    Intervention: Drug: SKI-606
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: 3
    Moxifloxacin
    Intervention: Drug: Moxifloxacin
  • Experimental: 4
    SKI-606 plus ketoconazole
    Intervention: Drug: SKI-606
  • Placebo Comparator: 5
    Placebo plus ketoconazole
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2009
August 2009   (Final data collection date for primary outcome measure)
Inclusion Criteria: Men or women of nonchildbearing potential; 18-50 years old; healthy as determined by the investigator, including physical examination, laboratory test results, and medical history.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00914121
3160A4-105
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
September 2009

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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