NCT00934674

Brief Summary

This study is comparing 2 formulations of bosutinib in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2009

Shorter than P25 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

July 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
24 days 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

1 month

First QC Date

July 2, 2009

Last Update Submit

September 1, 2009

Conditions

Healthy

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics as measured by Cmax, AUC, tmax, and t1/2

    2 weeks

Study Arms (2)

1

EXPERIMENTAL

Commercial Tablet manufactured by Excella

Drug: SKI-606 (Bosutinib)

2

EXPERIMENTAL

Clinical Tablet manufactured by Wyeth Montreal

Drug: SKI-606 (Bosutinib)

Interventions

SKI-606 (Bosutinib)DRUG

Arm 1 - Commercial Tablet manufactured by Excella Arm 2 - Clinical Tablet manufactured by Wyeth Montreal

Also known as: Bosutinib
12

Eligibility Criteria

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

You may qualify if:

  • Men or women of non-childbearing potential, age 18 to 50 years.

You may not qualify if:

  • Any significant cardiovascular, renal, hepatic, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Contact the study team to confirm eligibility.

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 8, 2009

Study Start

July 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)