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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: SKI-606; Drug: Moxifloxacin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914121

3160A4-105

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

SKI-606 alone

Treatment:

Drug: SKI-606

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

3

Active Comparator group

Description:

Moxifloxacin

Treatment:

Drug: Moxifloxacin

4

Experimental group

Description:

SKI-606 plus ketoconazole

Treatment:

Drug: SKI-606

5

Placebo Comparator group

Description:

Placebo plus ketoconazole

Treatment:

Drug: Placebo