Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban

Assistance Publique - Hôpitaux de Paris64 enrolled

Overview

The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

D->R->C+RDRUG

one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg

D->R->C+DDRUG

one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg

R->D->C+DDRUG

RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy participants * Aged between 18-35 years inclusive * Male * Caucasian * Body mass index (BMI) between 18 and 27 kg per m² inclusive.

Locations (1)

CIC Hopital europeen george pompidou

Paris, Paris, France

Outcomes

Primary Outcomes

AUC of plasma concentrations of the drugs

Time frame: over 24h after single oral dose

Secondary Outcomes

PKD of the drugs

Time frame: over 24h after single oral dose

Data from ClinicalTrials.gov

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