NCT02102633CompletedPhase 1
An Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of A Single Oral Dose Of Bosutinib On The Pharmacokinetics Of Dabigatran Etexilate Mesylate Administered Orally To Healthy Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Dabigatran
Experimental
Dabigatran 150 mg orally
Intervention: Dabigatran (Drug)
Dabigatran + Bosutinib
Experimental
Dabigatran 150 mg co-administered with Bosutinib 500 mg orally
Intervention: Bosutinib (Drug)
Dabigatran + Bosutinib
Experimental
Dabigatran 150 mg co-administered with Bosutinib 500 mg orally
Intervention: Dabigatran (Drug)
Outcomes
Primary Outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 48 hours
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 48 hours
Maximum Observed Plasma Concentration
Secondary Outcomes
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(48 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(48 hours)
- Plasma Decay Half-Life (t1/2)(48 hours)
- Apparent Oral Clearance (CL/F)(48 hours)
- Apparent Volume of Distribution (Vz/F)(48 hours)
Investigators
Study Sites (1)
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