RICHAR2: Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04767776

Collaborator

(none)

Enrollment

Location

Arms

11.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Rivaroxaban Drug: Activated charcoal	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 3, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Adverse events [24 hour after rivaroxaban administration]
Analysis adverse events related to the administration of treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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 ...)