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

NCT ID: NCT04767776

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2022-11-04

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

rivaroxaban 40 mg/day (1 day).

Activated charcoal

Intervention Type: DRUG

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

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)

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

rivaroxaban 40 mg/day (1 day).

Activated charcoal

Intervention Type: DRUG

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

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)

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

rivaroxaban 40 mg/day (1 day).

Activated charcoal

Intervention Type: DRUG

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

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)

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

rivaroxaban 40 mg/day (1 day).

Activated charcoal

Intervention Type: DRUG

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

Interventions

Rivaroxaban

rivaroxaban 40 mg/day (1 day).

Intervention Type: DRUG

Activated charcoal

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

Intervention Type: DRUG

Eligibility 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 ...)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick MISMETTI, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Countries

France

Other Identifiers

2019-004425-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18CH050

Identifier Type: -

Identifier Source: org_study_id