Drug Interaction Study Between Bosutinib And Dabigatran

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT02102633

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

26.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Dabigatran Drug: Bosutinib Drug: Dabigatran	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dabigatran Dabigatran 150 mg orally	Drug: Dabigatran Dabigatran 150 mg orally
Experimental: Dabigatran + Bosutinib Dabigatran 150 mg co-administered with Bosutinib 500 mg orally	Drug: Bosutinib Bosutinib 500 mg orally Drug: Dabigatran Dabigatran 150 mg orally

Arm

Intervention/Treatment

Experimental: Dabigatran

Dabigatran 150 mg orally

Drug: Dabigatran

Dabigatran 150 mg orally

Experimental: Dabigatran + Bosutinib

Dabigatran 150 mg co-administered with Bosutinib 500 mg orally

Drug: Bosutinib

Bosutinib 500 mg orally

Drug: Dabigatran

Dabigatran 150 mg orally

Outcome Measures

Primary Outcome Measures

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [48 hours]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Maximum Observed Plasma Concentration (Cmax) [48 hours]
Maximum Observed Plasma Concentration

Secondary Outcome Measures

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [48 hours]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time to Reach Maximum Observed Plasma Concentration (Tmax) [48 hours]
Time to Reach Maximum Observed Plasma Concentration
Plasma Decay Half-Life (t1/2) [48 hours]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F) [48 hours]
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Apparent Volume of Distribution (Vz/F) [48 hours]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

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.