Tacoma, Washington, 98418, United States
NCT Number: NCT00914121
Study Evaluating The Effect of Bosutinib (SKI-606) On Cardiac Repolarization (Rhythms Of The Heart)
The purpose of this study is to examine the effect of SKI-606 on rhythms of the heart (cardiac repolarization)
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
SKI-606
DrugOther names: Bosutinib
Placebo
Drugmoxifloxacin
DrugPrimary outcomes
-
Corrected QT interval, including QTcN, QTcB, and QTcF
Time frame: 6 weeks
Secondary outcomes
-
Laboratory evaluations, Vital Sign measurements, Adverse Event reports
Time frame: 6 weeks
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Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Industry
Registry information
Official study title
A Single Dose, Crossover, Placebo- and Moxifloxacin- Controlled Study of the Effects of Bosutinib on Cardiac Repolarization in Healthy Adult Subjects
Important dates
- Study start
- 2009
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Jun 4, 2009
- Registry last updated
- Sep 2, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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