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Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01734772
First received: November 15, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes

November 15, 2012
May 15, 2013
November 2012
March 2013   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • pharmacokinetic interaction (Cmax,ss of dabigatran [maximum measured concentration over the uniform dosing interval under steady state conditions]) [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01734772 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor
Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor Under Steady State Conditions in Healthy Male Subjects

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)
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
48
May 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

1. Healthy male subjects.

Exclusion criteria:

1. Any relevant deviation from healthy conditions.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01734772
1160.142, 2012-002656-16
Not Provided
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
May 2013

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