Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

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: Healthy
• Intervention / Treatment: Drug: dabigatran etexilate; Drug: dabigatran etexilate; Drug: dabigatran etexilate; Drug: ticagrelor; Drug: ticagrelor

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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)	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)	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

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

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: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Ticagrelor; Dabigatran
• Other Study ID Numbers: 1160.142; 2012-002656-16 (EudraCT Number: EudraCT)