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Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects (RICHAR)

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ClinicalTrials.gov Identifier: NCT02657512
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: rivaroxaban Drug: rivaroxaban and activated charcoal Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Official Title: Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects : RICHAR Study
Study Start Date : January 2016
Actual Primary Completion Date : February 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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"
Drug: rivaroxaban
rivaroxaban 40 mg/day (1 day)

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)

Experimental: 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"
Drug: rivaroxaban
rivaroxaban 40 mg/day (1 day)

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)

Experimental: 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"
Drug: rivaroxaban
rivaroxaban 40 mg/day (1 day)

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)




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657512


Locations
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France
CHU de SAINT-ETIENNE
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Patrick MISMETTI, MD PhD CHU de SAINT-ETIENNE

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02657512     History of Changes
Other Study ID Numbers: 1508030
2015-001839-21 ( EudraCT Number )
140096A-21 ( Other Identifier: ANSM )
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Rivaroxaban, pharmacokinetics, activated charcoal, poisoning

Additional relevant MeSH terms:
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Rivaroxaban
Charcoal
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Antidotes
Protective Agents
Physiological Effects of Drugs