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Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

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ClinicalTrials.gov Identifier: NCT01734772
Recruitment Status : Completed
First Posted : November 28, 2012
Results First Posted : May 5, 2014
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE November 15, 2012
First Posted Date  ICMJE November 28, 2012
Results First Submitted Date  ICMJE April 2, 2014
Results First Posted Date  ICMJE May 5, 2014
Last Update Posted Date May 5, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
  • Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) [ Time Frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours ]
    Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss).
  • Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss) [ Time Frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours ]
    Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).
Original Primary Outcome Measures  ICMJE
 (submitted: November 22, 2012)
  • pharmacokinetic interaction (AUCt,ss of dabigatran [Area under the curve over the dosing interval t under steady state conditions]) [ Time Frame: up to 12 hours ]
  • pharmacokinetic interaction (Cmax,ss of dabigatran [maximum measured concentration over the uniform dosing interval under steady state conditions]) [ Time Frame: up to 12 hours ]
Change History Complete list of historical versions of study NCT01734772 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor
Official Title  ICMJE Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor Under Steady State Conditions in Healthy Male Subjects
Brief Summary To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran exposure (in Part II)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: dabigatran etexilate
    multiple doses of dabigatran
  • Drug: dabigatran etexilate
    medium dose dabigatran
  • Drug: ticagrelor
    loading dose of ticagrelor
  • Drug: ticagrelor
    multiple doses of ticagrelor
  • Drug: dabigatran etexilate
    single dose of dabigatran
Study Arms  ICMJE
  • Experimental: Reference (Part 1/A, Part 2/C)
    multiple doses of dabigatran (alone)
    Intervention: Drug: dabigatran etexilate
  • Experimental: Test 1 (Part 1/Treatment B)
    concomitant administration of dabigatran and ticagrelor
    Interventions:
    • Drug: dabigatran etexilate
    • Drug: ticagrelor
    • Drug: ticagrelor
  • Experimental: Test 2 (Part 2/Treatment D)
    staggered administration of ticagrelor and dabigatran
    Interventions:
    • Drug: ticagrelor
    • Drug: dabigatran etexilate
Publications * Not Provided

*   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: November 22, 2012)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

1. Healthy male subjects.

Exclusion criteria:

1. Any relevant deviation from healthy conditions.

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01734772
Other Study ID Numbers  ICMJE 1160.142
2012-002656-16 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date April 2014

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