Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban

Conditions

Healthy Volunteers

Keywords

dabigatran, rivaroxaban, PKC, PKD, p-glycoprotein, polymorphism

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.

Ambre de Fautereau-Vassel, Antoine Mokhtarian, Manon Mangenot, Ombeline Krekounian, Isabelle Kousignian et al. (9 authors)

International Journal of Laboratory Hematology2023-09-144 citations

10.1111/ijlh.14166

Study of thrombin generation with St Genesia to evaluate xaban pharmacodynamics: Analytical performances over 18 months.

Foulon-Pinto G, Jourdi G, Perrin J, Abdoul J, Paris G, Gouin-Thibault I, Curis E, Lecompte T, Siguret V.

2020-12-288 citations

10.1111/ijlh.13443

Rivaroxaban pharmacodynamics in healthy volunteers evaluated with thrombin generation and the active protein C system: Modeling and assessing interindividual variability.

Siguret V, Abdoul J, Delavenne X, Curis E, Carlo A, Blanchard A, Salem JE, Gaussem P, Funck-Brentano C, Azizi M, Mismetti P, Loriot MA, Lecompte T, Gouin-Thibault I.

2019-07-0927 citations

10.1111/jth.14541

P-glycoprotein influences urinary excretion of aldosterone in healthy individuals

Pedro Marques, Pierre‐Yves Courand, Isabelle Gouin‐Thibault, Valentina Zhygalina, Damien Bergerot et al. (10 authors)

Journal of Hypertension2019-06-056 citations

10.1097/hjh.0000000000002150

Interventions

DRUGD->R->C+R

one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg

DRUGD->R->C+D

one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg

DRUGR->D->C+D

RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg

DRUGR->D->C+R

RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
AUC of plasma concentrations of the drugs	over 24h after single oral dose

Secondary

Measure	Time frame
PKD of the drugs	over 24h after single oral dose

Countries

France

Outcome results

None listed