Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban (DRIVING)

This study is currently recruiting participants.
Verified March 2011 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01627665
First received: April 27, 2012
Last updated: September 17, 2013
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: D->R->C+R
Drug: D->R->C+D
Drug: R->D->C+D
Drug: R->D->C+R
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: New Oral Anticoagulant Drugs Dabigatran Etexilate and Rivaroxaban: Influence of Genetic Factors in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • AUC of plasma concentrations of the drugs [ Time Frame: over 24h after single oral dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PKD of the drugs [ Time Frame: over 24h after single oral dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: D->R->C+R
sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with rivaroxaban
Drug: D->R->C+R
one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
Active Comparator: D->R->C+D
sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with Dabigatran
Drug: D->R->C+D
one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
Active Comparator: R->D->C+D
sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with Dabigatran
Drug: R->D->C+D
RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
Active Comparator: R->D->C+R
sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with rivaroxaban
Drug: R->D->C+R
RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627665

Contacts
Contact: Anne Blanchard, MD +33 1 56 09 29 13 anne.blanchard@egp.aphp.fr

Locations
France
CIC Hopital europeen george pompidou Recruiting
Paris, France, 75015
Contact: anne blanchard    00 33 (1) 56 09 29 13    anne.blanchard@egp.aphp.fr   
Principal Investigator: Anne Blanchard, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Anne Blanchard, MD CIC HEGP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01627665     History of Changes
Other Study ID Numbers: P081208
Study First Received: April 27, 2012
Last Updated: September 17, 2013
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Assistance Publique - Hôpitaux de Paris:
dabigatran
rivaroxaban
PKC
PKD
p-glycoprotein
polymorphism

Additional relevant MeSH terms:
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014