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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
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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Brief Summary:
The purpose of this study is to examine the effect of SKI-606 on rhythms of the heart (cardiac repolarization)

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: SKI-606 Drug: Placebo Drug: Moxifloxacin Phase 1

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Corrected QT interval, including QTcN, QTcB, and QTcF [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Laboratory evaluations, Vital Sign measurements, Adverse Event reports [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Washington
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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