Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01734772
First received: November 15, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Healthy
Drug: dabigatran etexilate
Drug: ticagrelor
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor Under Steady State Conditions in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).


Enrollment: 48
Study Start Date: November 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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:

1. Any relevant deviation from healthy conditions.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01734772

Locations
Germany
1160.142.1 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: NCT01734772     History of Changes
Other Study ID Numbers: 1160.142, 2012-002656-16
Study First Received: November 15, 2012
Results First Received: April 2, 2014
Last Updated: April 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014