Drug Interaction Study Between Bosutinib And Dabigatran

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-06-30

Brief Summary

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The study evaluates the effect of a single oral dose of bosutinib on the single dose pharmacokinetics of dabigatran, a p-glycoprotein substrate, in healthy subjects.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Dabigatran

Dabigatran 150 mg orally

Group Type EXPERIMENTAL

Dabigatran

Intervention Type DRUG

Dabigatran 150 mg orally

Dabigatran + Bosutinib

Dabigatran 150 mg co-administered with Bosutinib 500 mg orally

Group Type EXPERIMENTAL

Bosutinib

Intervention Type DRUG

Bosutinib 500 mg orally

Dabigatran

Intervention Type DRUG

Dabigatran 150 mg orally

Interventions

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Dabigatran

Dabigatran 150 mg orally

Intervention Type DRUG

Bosutinib

Bosutinib 500 mg orally

Intervention Type DRUG

Dabigatran

Dabigatran 150 mg orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects between 21 to 55 years old and BMI between 17.5 and 30.5 kg/m2.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Risks of bleeding including prior personal or familiar history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder or abnormal coagulation test (PT/INR or PTT/aPTT greater than upper limit of normal) result at screening.
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes