CompletedNCT00934674Updated Sep 2, 2009

Study Comparing Two Different Tablet Formulations Of Bosutinib

A Phase 1 interventional study of SKI-606 (Bosutinib) in Healthy, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-09-02.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study summary

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

Conditions studied

Healthy

Keywords

Healthy Subjects

In context

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 30 participants (estimated)

Study arms

Experimental
1
Commercial Tablet manufactured by Excella
Drug: SKI-606 (Bosutinib)
Experimental
2
Clinical Tablet manufactured by Wyeth Montreal
Drug: SKI-606 (Bosutinib)

Interventions

DrugSKI-606 (Bosutinib)
Arm 1 - Commercial Tablet manufactured by Excella Arm 2 - Clinical Tablet manufactured by Wyeth Montreal
Also known as: Bosutinib

What researchers measure

Primary outcomes

Pharmacokinetics as measured by Cmax, AUC, tmax, and t1/2
Time frame: 2 weeks

Study locations

1 site

Tacoma, Washington 98418, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00934674
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: Jul 8, 2009
Start date: Jul 2009
Primary completion: Aug 2009
Completion: Aug 2009
Last update: Sep 2, 2009

Study contacts

Medical Monitor

study director · Wyeth is now a wholly owned subsidiary of Pfizer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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