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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

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)

Condition or disease Intervention/treatment Phase
Healthy Drug: dabigatran etexilate Drug: ticagrelor Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor Under Steady State Conditions in Healthy Male Subjects
Study Start Date : November 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Reference (Part 1/A, Part 2/C)
multiple doses of dabigatran (alone)
Drug: dabigatran etexilate
medium dose dabigatran
Experimental: Test 1 (Part 1/Treatment B)
concomitant administration of dabigatran and ticagrelor
Drug: dabigatran etexilate
multiple doses of dabigatran
Drug: ticagrelor
loading dose of ticagrelor
Drug: ticagrelor
multiple doses of ticagrelor
Experimental: Test 2 (Part 2/Treatment D)
staggered administration of ticagrelor and dabigatran
Drug: ticagrelor
loading dose of ticagrelor
Drug: dabigatran etexilate
single dose of dabigatran



Primary Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male subjects.

Exclusion criteria:

1. Any relevant deviation from healthy conditions.


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): NCT01734772


Locations
Germany
1160.142.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01734772     History of Changes
Other Study ID Numbers: 1160.142
2012-002656-16 ( EudraCT Number: EudraCT )
First Posted: November 28, 2012    Key Record Dates
Results First Posted: May 5, 2014
Last Update Posted: May 5, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Ticagrelor
Dabigatran
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants