The purpose of this study is to examine the effect of SKI-606 on rhythms of the heart (cardiac repolarization)
determined by the investigator, including physical examination, laboratory test results,
and medical history.
determined by the investigator, including physical examination, laboratory test results,
and medical history.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating The Effect of Bosutinib (SKI-606) On Cardiac Repolarization (Rhythms Of The Heart) | |||
| Official Title ICMJE | A Single Dose, Crossover, Placebo- and Moxifloxacin- Controlled Study of the Effects of Bosutinib on Cardiac Repolarization in Healthy Adult Subjects | |||
| Brief Summary | The purpose of this study is to examine the effect of SKI-606 on rhythms of the heart (cardiac repolarization) | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
| Condition ICMJE | Healthy Subjects | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| 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 | 60 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | August 2009 | |||
| Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | 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. | |||
| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 50 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00914121 | |||
| Other Study ID Numbers ICMJE | 3160A4-105 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | September 2009 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
