Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

April 2, 2014 updated by: Boehringer Ingelheim

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Biberach, Germany
        • 1160.142.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion criteria:

1. Healthy male subjects.

Exclusion criteria:

1. Any relevant deviation from healthy conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours
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).
47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 22, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

May 5, 2014

Last Update Submitted That Met QC Criteria

April 2, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.142
  • 2012-002656-16 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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