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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rivaroxaban; Drug: Activated charcoal

• Registration Number: NCT04767776
• Lead Sponsor: 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-23
• Study Start: 2022-01-03
• Primary Completion: 2022-09-26
• Study Completion: 2022-11-04
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 ...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm D	Rivaroxaban	* 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)
Arm A	Rivaroxaban	* 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)
Arm A	Activated charcoal	* 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)
Arm B	Rivaroxaban	* 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)
Arm B	Activated charcoal	* 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)
Arm C	Rivaroxaban	* 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)
Arm C	Activated charcoal	* 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)
Arm D	Activated charcoal	* 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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse events	24 hour after rivaroxaban administration	Analysis adverse events related to the administration of treatment.

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France