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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: SKI-606; Drug: Placebo; Drug: Moxifloxacin

• Registration Number: NCT00914121
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-28
• Study Start: 2009-06
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-04
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-01
• Last Update Posted: 2009-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	SKI-606	SKI-606 alone
2	Placebo	Placebo
3	Moxifloxacin	Moxifloxacin
4	SKI-606	SKI-606 plus ketoconazole
5	Placebo	Placebo plus ketoconazole

Primary Outcome Measures

Name	Time	Method
Corrected QT interval, including QTcN, QTcB, and QTcF	6 weeks

Secondary Outcome Measures

Name	Time	Method
Laboratory evaluations, Vital Sign measurements, Adverse Event reports	6 weeks