Drug Interaction Study Between Bosutinib And Dabigatran

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02102633

Run by

Pfizer

People needed

27

Starts

2014-05-01

Expected to finish

2014-06-01

Last updated by the study team

2014-06-24

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — DeLand, Florida, United States

Full record on ClinicalTrials.gov

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