Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban

Phase 2

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: D->R->C+D; Drug: D->R->C+R; Drug: R->D->C+D; Drug: R->D->C+R

• Registration Number: NCT01627665
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2011-03
• Study Start: 2011-10
• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-26
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-10-08
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
D->R->C+D	D->R->C+D	sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with Dabigatran
D->R->C+R	D->R->C+R	sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with rivaroxaban
R->D->C+D	R->D->C+D	sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with Dabigatran
R->D->C+R	R->D->C+R	sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with rivaroxaban

Primary Outcome Measures

Name	Time	Method
AUC of plasma concentrations of the drugs	over 24h after single oral dose

Secondary Outcome Measures

Name	Time	Method
PKD of the drugs	over 24h after single oral dose

Trial Locations

Locations (1)

CIC Hopital europeen george pompidou; 🇫🇷 Paris, France