Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects (RICHAR)

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: rivaroxaban and activated charcoal; Drug: rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT02657512

140096A-21 (Other Identifier)

1508030

2015-001839-21 (EudraCT Number)

Details and patient eligibility

About

Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X. Bleeding events related to rivaroxaban are the consequence of physiopathologic, pharmacokinetic issues or poisoning. Few results are available on the use of activated charcoal in rivaroxaban poisoning. Moreover, a recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to apixaban (a direct oral anticoagulant of the same class). The objective of this study is to evaluate the effect of activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four treatments modalities will be studied: rivaroxaban alone and rivaroxaban with activated charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• affiliated or beneficiary of a social security category
• having signed the inform consent form
• having signed the genetic consent form
• BMI between 18.5 and 25
• normal clinical exam
• normal biological exam

Exclusion criteria

• contra-indication to rivaroxaban
• contra-indication to activated charcoal
• previous history of psychiatric disease, or antidepressant treatment, or convulsion, or hemorrhagic disease smoker
• Organic lesion likely to bleed
• severe liver disease
• severe kidney failure
• previous surgery within one month

Trial design

12 participants in 3 patient groups

Arm A

Experimental group

Description:

* Period " rivaroxaban alone" * Washout period (at least 6 days) * Period " rivaroxaban and activated charcoal 2 hours after rivaroxaban administration" * Washout period (at least 6 days) * Period " " rivaroxaban and activated charcoal 5 hours after rivaroxaban administration"

Treatment:

Drug: rivaroxaban

Drug: rivaroxaban and activated charcoal

Arm B

Experimental group

Description:

. Period " rivaroxaban and activated charcoal 5 hours after rivaroxaban administration" * Washout period (at least 6 days) * Period " rivaroxaban alone" * Washout period (at least 6 days) * Period " " rivaroxaban and activated charcoal 8 hours after rivaroxaban administration"

Treatment:

Drug: rivaroxaban

Drug: rivaroxaban and activated charcoal

Arm C

Experimental group

Description:

. Period " rivaroxaban and activated charcoal 2 hours after rivaroxaban administration" * Washout period (at least 6 days) * Period " " rivaroxaban and activated charcoal 8 hours after rivaroxaban administration" * Washout period (at least 6 days) * Period " rivaroxaban alone"

Treatment:

Drug: rivaroxaban

Drug: rivaroxaban and activated charcoal