drugset / Trial / NCT02657512

Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects

NCT02657512

Phase 1 Completed 12 enrolled University Hospital of Saint-Etienne
RandomizedFactorialSingle-blind

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.

Timeline

Start
2016-01
Primary completion
2016-02
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Activated Charcoal Other / unclassified 50 g
Subject Rivaroxaban Other / unclassified 40 mg Oral

Indications

No indication recorded.