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NCT01627665 Clinical Trial

Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban

Healthy Volunteers Clinical Trial

— DRIVING  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01627665
Other study ID # P081208
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received April 27, 2012
Last updated October 8, 2014
Start date October 2011
Est. completion date June 2014

Study information
Verified date March 2011
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy participants

- Aged between 18-35 years inclusive

- Male

- Caucasian

- Body mass index (BMI) between 18 and 27 kg per m² inclusive.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• D->R->C+R
one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
• D->R->C+D
one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
• R->D->C+D
RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
• R->D->C+R
RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg

Locations
Country Name City State
France CIC Hopital europeen george pompidou Paris

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUC of plasma concentrations of the drugs over 24h after single oral dose No
Secondary PKD of the drugs over 24h after single oral dose Yes
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