Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: rivaroxaban; Drug: rivaroxaban and activated charcoal

• Registration Number: NCT02657512
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-18
• Primary Completion: 2016-02
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-24
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm C	rivaroxaban and activated charcoal	. 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"
Arm A	rivaroxaban and activated charcoal	* 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"
Arm B	rivaroxaban and activated charcoal	. 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"
Arm A	rivaroxaban	* 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"
Arm B	rivaroxaban	. 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"
Arm C	rivaroxaban	. 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"

Primary Outcome Measures

Name	Time	Method
plasma concentrations of rivaroxaban	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

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France