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

Healthy Clinical Trial

— RICHAR2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767776
• Other study ID #: 18CH050
• Secondary ID: 2019-004425-25
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2022
• Est. completion date: November 4, 2022

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 4, 2022
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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 ...)

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma concentrations of rivaroxaban	rivaroxaban pharmacokinetics	1, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 24 hours after rivaroxaban administration
Secondary	Adverse events	Analysis adverse events related to the administration of treatment.	24 hour after rivaroxaban administration