NCT00914121

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 2, 2009

Status Verified

September 1, 2009

Enrollment Period

2 months

First QC Date

May 28, 2009

Last Update Submit

September 1, 2009

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Corrected QT interval, including QTcN, QTcB, and QTcF

    6 weeks

Secondary Outcomes (1)

  • Laboratory evaluations, Vital Sign measurements, Adverse Event reports

    6 weeks

Study Arms (5)

1

EXPERIMENTAL

SKI-606 alone

Drug: SKI-606

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

3

ACTIVE COMPARATOR

Moxifloxacin

Drug: Moxifloxacin

4

EXPERIMENTAL

SKI-606 plus ketoconazole

Drug: SKI-606

5

PLACEBO COMPARATOR

Placebo plus ketoconazole

Drug: Placebo

Interventions

SKI-606DRUG
Also known as: Bosutinib
14
PlaceboDRUG
25
MoxifloxacinDRUG
3

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Interventions

bosutinibMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 4, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 2, 2009

Record last verified: 2009-09

Locations

US(1)