Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: dabigatran etexilate; Drug: ticagrelor

• Registration Number: NCT01734772
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-22
• Study First Posted: 2012-11-28
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-04
• Results First Submitted: 2014-04-02
• Results First Submitted QC: 2014-04-02
• Last Update Submitted: 2014-04-02
• Results First Posted: 2014-05-05
• Last Update Posted: 2014-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test 1 (Part 1/Treatment B)	dabigatran etexilate	concomitant administration of dabigatran and ticagrelor
Test 2 (Part 2/Treatment D)	dabigatran etexilate	staggered administration of ticagrelor and dabigatran
Test 2 (Part 2/Treatment D)	ticagrelor	staggered administration of ticagrelor and dabigatran
Reference (Part 1/A, Part 2/C)	dabigatran etexilate	multiple doses of dabigatran (alone)
Test 1 (Part 1/Treatment B)	ticagrelor	concomitant administration of dabigatran and ticagrelor

Primary Outcome Measures

Name	Time	Method
Total Dabigatran: Area Under the Concentration-time Curve 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	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)	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).

Trial Locations

Locations (1)

1160.142.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany