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

• Status: Not yet recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: Male

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. 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Treatments: Charcoal; Rivaroxaban

Criteria

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 ...)