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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01595854
First received: May 9, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: dabigatran etexilate
Drug: Ticagrelor
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran.

  • 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 ] [ Designated as safety issue: No ]
    Maximum measured concentration of total dabigatran in plasma, per period.


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


Enrollment: 36
Study Start Date: May 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy male subjects

    Exclusion criteria:

  2. Any relevant deviation from healthy conditions
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01595854

Locations
Germany
1160.141.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01595854     History of Changes
Other Study ID Numbers: 1160.141, 2012-000874-42
Study First Received: May 9, 2012
Results First Received: June 18, 2013
Last Updated: June 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on July 31, 2014