Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects

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.

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Key information

Conditions

Healthy Anthrax Bacillaceae Infections Bacterial Infections Bacterial Infections and Mycoses Chemically-Induced Disorders Gram-Positive Bacterial Infections Infections Poisoning

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban

Drug

rivaroxaban 40 mg/day (1 day)

rivaroxaban and activated charcoal

Drug

rivaroxaban 40 mg/day (1 day) and 50 g of activated charcoal 2 or 5 or 8 hours after rivaroxaban administration (1 day)

Primary outcomes

plasma concentrations of rivaroxaban

Time frame: H0.5, H0.75, H1, H1.5, H2, H2.5, H3, H4, H5, H6, H8, H10, H12, H14, H18 and H24 after rivaroxaban administration

rivaroxaban pharmacokinetics

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects : RICHAR Study

Acronym: RICHAR

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jan 18, 2016
Registry last updated: May 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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