Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
New Oral Anticoagulant Drugs Dabigatran Etexilate and Rivaroxaban: Influence of Genetic Factors in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: D->R->C+R
* Drug: D->R->C+D
* Drug: R->D->C+D
* Drug: R->D->C+R


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D->R->C+R<br>sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with rivaroxaban | Drug: D->R->C+R<br>* one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg<br>|
| Active Comparator: D->R->C+D<br>sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with Dabigatran | Drug: D->R->C+D<br>* one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg<br>|
| Active Comparator: R->D->C+D<br>sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with Dabigatran | Drug: R->D->C+D<br>* RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg<br>|
| Active Comparator: R->D->C+R<br>sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with rivaroxaban | Drug: R->D->C+R<br>* RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of plasma concentrations of the drugs |  | over 24h after single oral dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PKD of the drugs |  | over 24h after single oral dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dabigatran, rivaroxaban, PKC, PKD, p-glycoprotein, polymorphism