NCT00406406

Brief Summary

Safety and tolerability of SKI-606 in healthy subjects; the influence of food intake on the same.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2006

Typical duration for phase_1 healthy

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

Study Start

First participant enrolled

November 1, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 5, 2007

Status Verified

December 1, 2007

First QC Date

November 29, 2006

Last Update Submit

December 3, 2007

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics; safety and tolerability; influence of food.

Interventions

Eligibility Criteria

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

You may qualify if:

  • Healthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Utrecht, 3584 CJ, Netherlands

Location

MeSH Terms

Interventions

bosutinib

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR
  • Trial Manager

    For Netherlands, trials-NL@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 29, 2006

First Posted

December 4, 2006

Study Start

November 1, 2006

Study Completion

August 1, 2007

Last Updated

December 5, 2007

Record last verified: 2007-12

Locations