NCT00757341

Brief Summary

This study will assess the mass balance, metabolic disposition, and identification of metabolites following single oral administration of \[14C\]-SKI-606 in healthy male subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2008

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

September 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 27, 2009

Status Verified

April 1, 2009

Enrollment Period

Same day

First QC Date

September 19, 2008

Last Update Submit

April 24, 2009

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Mass Balance and Metabolic Disposition

    10 days

Study Arms (1)

SKI-606

EXPERIMENTAL
Drug: SKI-606

Interventions

SKI-606DRUG
SKI-606

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Healthy men, aged 18 to 50 years.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Interventions

bosutinib

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 23, 2008

Study Start

December 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 27, 2009

Record last verified: 2009-04

Locations

US(1)