NCT02657512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 25, 2016

Status Verified

May 1, 2016

Enrollment Period

1 month

First QC Date

January 14, 2016

Last Update Submit

May 24, 2016

Conditions

Healthy

Keywords

Rivaroxaban, pharmacokinetics, activated charcoal, poisoning

Outcome Measures

Primary Outcomes (1)

  • plasma concentrations of rivaroxaban

    rivaroxaban pharmacokinetics

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

Study Arms (3)

Arm A

EXPERIMENTAL

* 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"

Drug: rivaroxabanDrug: rivaroxaban and activated charcoal

Arm B

EXPERIMENTAL

. 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"

Drug: rivaroxabanDrug: rivaroxaban and activated charcoal

Arm C

EXPERIMENTAL

. 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"

Drug: rivaroxabanDrug: rivaroxaban and activated charcoal

Interventions

rivaroxabanDRUG

rivaroxaban 40 mg/day (1 day)

Arm AArm BArm C
rivaroxaban and activated charcoalDRUG

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

Arm AArm BArm C

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

Related Publications (1)

  • Ollier E, Hodin S, Lanoiselee J, Escal J, Accassat S, De Magalhaes E, Basset T, Bertoletti L, Mismetti P, Delavenne X. Effect of Activated Charcoal on Rivaroxaban Complex Absorption. Clin Pharmacokinet. 2017 Jul;56(7):793-801. doi: 10.1007/s40262-016-0485-1.

    PMID: 27910037DERIVED

MeSH Terms

Conditions

AnthraxPoisoning

Interventions

RivaroxabanCharcoal

Condition Hierarchy (Ancestors)

Bacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbonElementsInorganic Chemicals

Study Officials

  • Patrick MISMETTI, MD PhD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 18, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

May 25, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)