NCT00434486

Brief Summary

To investigate a potential pharmacokinetic interaction between SKI-606 and ketoconazole when co-administered.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2007

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

February 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

September 12, 2007

Status Verified

September 1, 2007

First QC Date

February 9, 2007

Last Update Submit

September 10, 2007

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics; safety and tolerability

Interventions

SKI-606DRUG

Eligibility Criteria

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

You may qualify if:

  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Philadelphia, Pennsylvania, 19148, 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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 13, 2007

Study Start

March 1, 2007

Study Completion

March 1, 2007

Last Updated

September 12, 2007

Record last verified: 2007-09

Locations

US(1)