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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00914121
First received: May 28, 2009
Last updated: September 1, 2009
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Subjects
 Drug: SKI-606
Drug: Placebo
Drug: Moxifloxacin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Corrected QT interval, including QTcN, QTcB, and QTcF [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Laboratory evaluations, Vital Sign measurements, Adverse Event reports [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00914121     History of Changes
Other Study ID Numbers: 3160A4-105
Study First Received: May 28, 2009
Last Updated: September 1, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
 Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013