Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm A

* 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"

Group Type EXPERIMENTAL

rivaroxaban

Intervention Type DRUG

rivaroxaban 40 mg/day (1 day)

rivaroxaban and activated charcoal

Intervention Type DRUG

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

Arm B

. 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"

Group Type EXPERIMENTAL

rivaroxaban

Intervention Type DRUG

rivaroxaban 40 mg/day (1 day)

rivaroxaban and activated charcoal

Intervention Type DRUG

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

Arm C

. 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"

Group Type EXPERIMENTAL

rivaroxaban

Intervention Type DRUG

rivaroxaban 40 mg/day (1 day)

rivaroxaban and activated charcoal

Intervention Type DRUG

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

Interventions

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rivaroxaban

rivaroxaban 40 mg/day (1 day)

Intervention Type DRUG

rivaroxaban and activated charcoal

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes