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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3; Phase 2

Conditions: Healthy Volunteers

Treatments: Drug: R->D->C+R; Drug: D->R->C+R; Drug: D->R->C+D; Drug: R->D->C+D

Study type: Interventional

Funder types: Other

Identifiers

NCT01627665

P081208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

64 participants in 4 patient groups

D->R->C+R

Active Comparator group

Description:

sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with rivaroxaban

Treatment:

Drug: D->R->C+R

D->R->C+D

Active Comparator group

Description:

sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with Dabigatran

Treatment:

Drug: D->R->C+D

R->D->C+D

Active Comparator group

Description:

sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with Dabigatran

Treatment:

Drug: R->D->C+D

R->D->C+R

Active Comparator group

Description:

sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with rivaroxaban

Treatment:

Drug: R->D->C+R