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:

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride Bosutinib

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 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

ClinicalTrials.gov processed this record on September 26, 2016

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