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Drug Interaction Study Between Bosutinib And Dabigatran

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
DeLand, Florida, 32720 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02102633
Pfizer
Completed
Drug Interaction Study Between Bosutinib And Dabigatran

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Drug Interaction Study Between Bosutinib And Dabigatran
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: Dabigatran
    Dabigatran 150 mg orally
  • Drug: Bosutinib
    Bosutinib 500 mg orally
  • Experimental: Dabigatran
    Dabigatran 150 mg orally
    Intervention: Drug: Dabigatran
  • Experimental: Dabigatran + Bosutinib
    Dabigatran 150 mg co-administered with Bosutinib 500 mg orally
    Interventions:
    • Drug: Bosutinib
    • Drug: Dabigatran
Hsyu PH, Pignataro DS, Matschke K. Effect of bosutinib on the absorption of dabigatran etexilate mesylate, a P-glycoprotein substrate, in healthy subjects. Eur J Clin Pharmacol. 2017 Jan;73(1):57-63. doi: 10.1007/s00228-016-2115-0. Epub 2016 Oct 7.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02102633
B1871043
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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