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

NCT04767776 | Completed Phase 1

• 2 other identifiers: 18CH0502019-004425-25
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Rivaroxaban,; Activated charcoal; Pharmacokinetics; Poisoning

Outcome Measures

Primary Outcomes (1)

• plasma concentrations of rivaroxaban

  rivaroxaban pharmacokinetics

  1, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 24 hours after rivaroxaban administration

Secondary Outcomes (1)

• Adverse events

  24 hour after rivaroxaban administration

Study Arms (4)

Arm A

EXPERIMENTAL

* 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; Drug: Activated charcoal

Arm B

EXPERIMENTAL

* 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; Drug: Activated charcoal

Arm C

EXPERIMENTAL

* 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; Drug: Activated charcoal

Arm D

EXPERIMENTAL

* 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; Drug: Activated charcoal

Interventions

Rivaroxaban DRUG

rivaroxaban 40 mg/day (1 day).

Arm A; Arm B; Arm C; Arm D

Activated charcoal DRUG

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

Arm A; Arm B; Arm C; Arm D

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 ...)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Anthrax; Poisoning

Interventions

Rivaroxaban; Charcoal

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbon; Elements; Inorganic Chemicals

Study Officials

• Patrick MISMETTI, MD PhD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 23, 2021
• Study Start: January 3, 2022
• Primary Completion: September 26, 2022
• Study Completion: November 4, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)