Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Treatments: Charcoal; Rivaroxaban

Criteria

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