Drug Interaction Study Between Bosutinib And Dabigatran

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Dabigatran; Drug: Bosutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02102633

B1871043

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

27 participants in 2 patient groups

Dabigatran

Experimental group

Description:

Dabigatran 150 mg orally

Treatment:

Drug: Dabigatran

Drug: Dabigatran

Dabigatran + Bosutinib

Experimental group

Description:

Dabigatran 150 mg co-administered with Bosutinib 500 mg orally

Treatment:

Drug: Dabigatran

Drug: Dabigatran

Drug: Bosutinib