Study Evaluating The Effect of Bosutinib (SKI-606) On Cardiac Repolarization (Rhythms Of The Heart)
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ClinicalTrials.gov Identifier: NCT00914121 |
Recruitment Status
:
Completed
First Posted
: June 4, 2009
Last Update Posted
: September 2, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Subjects | Drug: SKI-606 Drug: Placebo Drug: Moxifloxacin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Single Dose, Crossover, Placebo- and Moxifloxacin- Controlled Study of the Effects of Bosutinib on Cardiac Repolarization in Healthy Adult Subjects |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | August 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
SKI-606 alone
|
Drug: SKI-606
Other Name: Bosutinib
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo |
Active Comparator: 3
Moxifloxacin
|
Drug: Moxifloxacin |
Experimental: 4
SKI-606 plus ketoconazole
|
Drug: SKI-606
Other Name: Bosutinib
|
Placebo Comparator: 5
Placebo plus ketoconazole
|
Drug: Placebo |
- Corrected QT interval, including QTcN, QTcB, and QTcF [ Time Frame: 6 weeks ]
- Laboratory evaluations, Vital Sign measurements, Adverse Event reports [ Time Frame: 6 weeks ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914121
United States, Washington | |
Tacoma, Washington, United States, 98418 |
Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
Responsible Party: | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
ClinicalTrials.gov Identifier: | NCT00914121 History of Changes |
Other Study ID Numbers: |
3160A4-105 |
First Posted: | June 4, 2009 Key Record Dates |
Last Update Posted: | September 2, 2009 |
Last Verified: | September 2009 |
Additional relevant MeSH terms:
Moxifloxacin Fluoroquinolones Norgestimate, ethinyl estradiol drug combination Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Nucleic Acid Synthesis Inhibitors |