Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Bosutinib Administered Orally to Healthy Subjects

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Bosutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00721474

3160A4-1110

Details and patient eligibility

About

A Study to determine if a high-fat meal has an effect on the pharmacokinetics of bosutinib.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy men, age 18-50;
• Healthy women of nonchildbearing potential, age 18-50.

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

1

Experimental group

Description:

Bosutinib fasting

Treatment:

Drug: Bosutinib

Drug: Bosutinib

2

Experimental group

Description:

Bosutinib fed

Treatment:

Drug: Bosutinib

Drug: Bosutinib