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Drug Interaction Study Between Bosutinib And Dabigatran

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ClinicalTrials.gov Identifier: NCT02102633
Recruitment Status : Completed
First Posted : April 3, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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 Phase 1

Study Type : Interventional  (Clinical Trial)
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 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)

  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 48 hours ]
    Maximum Observed Plasma Concentration


Secondary Outcome Measures :
  1. 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)

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 48 hours ]
    Time to Reach Maximum Observed Plasma Concentration

  3. Plasma Decay Half-Life (t1/2) [ Time Frame: 48 hours ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  4. Apparent Oral Clearance (CL/F) [ Time Frame: 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.

  5. Apparent Volume of Distribution (Vz/F) [ Time Frame: 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.



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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102633


Locations
United States, Florida
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02102633     History of Changes
Other Study ID Numbers: B1871043
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Keywords provided by Pfizer:
bosutinib
dabigatran
drug interaction
p-glycoprotein
pharmacokinetics

Additional relevant MeSH terms:
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants