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Completed

NCT Number: NCT00914121

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

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

Completed

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Key information

Conditions

Healthy Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SKI-606

Drug

Other names: Bosutinib

Placebo

Drug

moxifloxacin

Drug

Primary outcomes

  1. Corrected QT interval, including QTcN, QTcB, and QTcF

    Time frame: 6 weeks

Secondary outcomes

  1. Laboratory evaluations, Vital Sign measurements, Adverse Event reports

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Single Dose, Crossover, Placebo- and Moxifloxacin- Controlled Study of the Effects of Bosutinib on Cardiac Repolarization in Healthy Adult Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 4, 2009
Registry last updated
Sep 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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