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

September 1, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Tacoma, Washington, United States, 98418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Placebo
Drug: Placebo
EXPERIMENTAL: 1
SKI-606 alone
Drug: SKI-606
Other Names:
  • Bosutinib
ACTIVE_COMPARATOR: 3
Moxifloxacin
Drug: Moxifloxacin
EXPERIMENTAL: 4
SKI-606 plus ketoconazole
Drug: SKI-606
Other Names:
  • Bosutinib
PLACEBO_COMPARATOR: 5
Placebo plus ketoconazole
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corrected QT interval, including QTcN, QTcB, and QTcF
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Laboratory evaluations, Vital Sign measurements, Adverse Event reports
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (ESTIMATE)

June 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2009

Last Update Submitted That Met QC Criteria

September 1, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3160A4-105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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