Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lansoprazole; Drug: Bosutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00952913

B1871002

3160A4-1108

Details and patient eligibility

About

The purpose of this study is to see if there is an effect on the pharmacokinetics of bosutinib when administered with lansoprazole.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women of nonchildbearing potential, between the ages of 18 to 50 years old.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

1

Experimental group

Description:

Bosutinib

Treatment:

Drug: Bosutinib

Drug: Bosutinib

2

Experimental group

Description:

bosutinib + lansoprazole

Treatment:

Drug: Bosutinib

Drug: Bosutinib

Drug: Lansoprazole