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Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran

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ClinicalTrials.gov Identifier: NCT01595854
Recruitment Status : Completed
First Posted : May 10, 2012
Results First Posted : August 22, 2013
Last Update Posted : August 22, 2013
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor (Part 1 and 2, Open, Non-randomised, 2 Parallel Groups) and Assessment of Ticagrelor Interaction Potential With Dabigatran (Part 3, Open, Randomised, Two-period Cross-over) in Healthy Male Subjects
Study Start Date : May 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Test 2 (part 3)
low dose dabigatran + high dose ticagrelor
Drug: Ticagrelor
high dose ticagrelor
Drug: dabigatran etexilate
medium dose dabigatran
Active Comparator: Test 1 (part 1 + 2)
high dose ticagrelor
Drug: Ticagrelor
high dose ticagrelor
Experimental: Reference 1 (part 1 + 2)
medium dose dabigatran
Drug: dabigatran etexilate
medium dose dabigatran
Experimental: Reference 2 (part 3)
low dose dabigatran
Drug: dabigatran etexilate
low dose dabigatran



Primary Outcome Measures :
  1. Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours ]
    Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran.

  2. Total Dabigatran: Maximum Measured Concentration (Cmax) [ Time Frame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours ]
    Maximum measured concentration of total dabigatran in plasma, per period.


Secondary Outcome Measures :
  1. Number of Participants With Drug Related Adverse Events [ Time Frame: From screening until the end-of-study examination ]
    The number of participants with drug related adverse events



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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:

  2. 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): NCT01595854


Locations
Germany
1160.141.1 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: NCT01595854     History of Changes
Other Study ID Numbers: 1160.141
2012-000874-42 ( EudraCT Number: EudraCT )
First Posted: May 10, 2012    Key Record Dates
Results First Posted: August 22, 2013
Last Update Posted: August 22, 2013
Last Verified: June 2013

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