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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01627665
First received: April 27, 2012
Last updated: June 10, 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627665

Locations
France
CIC Hopital europeen george pompidou
Paris, France, 75015
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: June 10, 2014
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 July 29, 2014