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

C

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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