Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 335 for:    DABIGATRAN

Drug Interaction Study Between Bosutinib And Dabigatran

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 31, 2014
First Posted Date  ICMJE April 3, 2014
Last Update Posted Date June 24, 2014
Study Start Date  ICMJE May 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02102633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
  • 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)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 48 hours ]
    Time to Reach Maximum Observed Plasma Concentration
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug Interaction Study Between Bosutinib And Dabigatran
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Dabigatran
    Dabigatran 150 mg orally
  • Drug: Bosutinib
    Bosutinib 500 mg orally
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2014)
27
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2014)
28
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02102633
Other Study ID Numbers  ICMJE B1871043
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP