Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics.

Overview

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. A recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to rivaroxaban. However, no results are available on the minimal dose of activated charcoal necessary in rivaroxaban poisoning. The objective of this study is to evaluate the effect of 4 dosing regimen 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 with 50g, 24g, 12g and 6g of activated charcoal administrated 3 hours after rivaroxaban intake.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2021

Interventions

  • Drug: Rivaroxaban
    • rivaroxaban 40 mg/day (1 day).
  • Drug: Activated charcoal
    • Activated charcoal 2 hours after rivaroxaban administration (1 day).

Arms, Groups and Cohorts

  • Experimental: Arm A
    • Period ” rivaroxaban and 6 milligram of activated charcoal “ Washout period (6 days) Period ” rivaroxaban and 12 milligram of activated charcoal “ Washout period (6 days) Period ” rivaroxaban and 50 milligram of activated charcoal “ Washout period (6 days)
  • Experimental: Arm B
    • Period ” rivaroxaban and 12 milligram of activated charcoal “ Washout period (6 days) Period ” rivaroxaban and 6 milligram of activated charcoal “ Washout period (6 days) Period ” rivaroxaban and 24 milligram of activated charcoal “ Washout period (6 days)
  • Experimental: Arm C
    • Period ” rivaroxaban and 50 milligram of activated charcoal “ Washout period (6 days) Period ” rivaroxaban and 24 milligram of activated charcoal “ Washout period (6 days) Period ” rivaroxaban and 6 milligram of activated charcoal “ Washout period (6 days)
  • Experimental: Arm D
    • Period ” rivaroxaban and 24 milligram of activated charcoal “ Washout period (6 days) Period ” rivaroxaban and 50 milligram of activated charcoal “ Washout period (6 days) Period ” rivaroxaban and 12 milligram of activated charcoal “ Washout period (6 days)

Clinical Trial Outcome Measures

Primary Measures

  • plasma concentrations of rivaroxaban
    • Time Frame: 1, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 24 hours after rivaroxaban administration
    • rivaroxaban pharmacokinetics

Secondary Measures

  • Adverse events
    • Time Frame: 24 hour after rivaroxaban administration
    • Analysis adverse events related to the administration of treatment.

Participating in This Clinical Trial

Inclusion Criteria

  • Affiliated or beneficiary of a social security category – Having signed the inform consent form – Having signed the biologic consent form – Men aged between 18 and 40 years – Weight between 55 and 92 kilogram – normal clinical exam – normal biological exam Exclusion Criteria:

  • Contra-indication to rivaroxaban – Contra-indication to activated charcoal – With a history of hemorrhagic disease – Smoker – Organic lesion likely to bleed – Severe liver disease – Severe kidney failure – Gastroduodenal ulcers – Any medication taken during the week prior to the start of the study – Consumption of grapefruit juice – Routine ingestion of excessive amounts of coffee, tea, chocolate and/or caffeinated beverages – Practice of violent sports – Fructose intolerance – Glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency syndrome – Notable medical history (cardiovascular pathology, pulmonary, neurology …)

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Saint Etienne
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patrick MISMETTI, MD PhD, Principal Investigator, CHU de SAINT-ETIENNE
  • Overall Contact(s)
    • Edouard OLLIER, MD, (0)477829512, edouard.ollier@univ-st-etienne.fr

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