Study Comparing Two Different Tablet Formulations Of Bosutinib

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SKI-606 (Bosutinib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00934674

3160A4-1115

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

1

Experimental group

Description:

Commercial Tablet manufactured by Excella

Treatment:

Drug: SKI-606 (Bosutinib)

2

Experimental group

Description:

Clinical Tablet manufactured by Wyeth Montreal

Treatment:

Drug: SKI-606 (Bosutinib)