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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ticagrelor; Drug: dabigatran etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01595854

1160.141

2012-000874-42 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

1. Healthy male subjects

   Exclusion criteria:

2. Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

Test 2 (part 3)

Experimental group

Description:

low dose dabigatran + high dose ticagrelor

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: Ticagrelor

Drug: Ticagrelor

Drug: dabigatran etexilate

Test 1 (part 1 + 2)

Active Comparator group

Description:

high dose ticagrelor

Treatment:

Drug: Ticagrelor

Drug: Ticagrelor

Reference 1 (part 1 + 2)

Experimental group

Description:

medium dose dabigatran

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Reference 2 (part 3)

Experimental group

Description:

low dose dabigatran

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate