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OpenTrials
Completed

NCT Number: NCT04767776

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

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.

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Key information

Conditions

Healthy Anthrax Bacillaceae Infections Bacterial Infections Bacterial Infections and Mycoses Chemically-Induced Disorders Gram-Positive Bacterial Infections Infections Poisoning

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 ...)

Treatment and study plan

Rivaroxaban

Drug

rivaroxaban 40 mg/day (1 day).

Activated Charcoal

Drug

Activated charcoal 2 hours after rivaroxaban administration (1 day).

Primary outcomes

  1. 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 outcomes

  1. Adverse events

    Time frame: 24 hour after rivaroxaban administration

    Analysis adverse events related to the administration of treatment.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: RICHAR2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2021
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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