Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects : RICHAR Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- plasma concentrations of rivaroxaban
Study Overview
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. Few results are available on the use of activated charcoal in rivaroxaban poisoning. Moreover, a recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to apixaban (a direct oral anticoagulant of the same class). The objective of this study is to evaluate the effect of 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 alone and rivaroxaban with activated charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •affiliated or beneficiary of a social security category
- •having signed the inform consent form
- •having signed the genetic consent form
- •BMI between 18.5 and 25
- •normal clinical exam
- •normal biological exam
Exclusion Criteria
- •contra-indication to rivaroxaban
- •contra-indication to activated charcoal
- •previous history of psychiatric disease, or antidepressant treatment, or convulsion, or hemorrhagic disease smoker
- •Organic lesion likely to bleed
- •severe liver disease
- •severe kidney failure
- •previous surgery within one month
Arms & Interventions
Arm A
- Period " rivaroxaban alone"
- Washout period (at least 6 days)
- Period " rivaroxaban and activated charcoal 2 hours after rivaroxaban administration"
- Washout period (at least 6 days)
- Period " " rivaroxaban and activated charcoal 5 hours after rivaroxaban administration"
Intervention: rivaroxaban (Drug)
Arm A
- Period " rivaroxaban alone"
- Washout period (at least 6 days)
- Period " rivaroxaban and activated charcoal 2 hours after rivaroxaban administration"
- Washout period (at least 6 days)
- Period " " rivaroxaban and activated charcoal 5 hours after rivaroxaban administration"
Intervention: rivaroxaban and activated charcoal (Drug)
Arm B
. Period " rivaroxaban and activated charcoal 5 hours after rivaroxaban administration"
- Washout period (at least 6 days)
- Period " rivaroxaban alone"
- Washout period (at least 6 days)
- Period " " rivaroxaban and activated charcoal 8 hours after rivaroxaban administration"
Intervention: rivaroxaban (Drug)
Arm B
. Period " rivaroxaban and activated charcoal 5 hours after rivaroxaban administration"
- Washout period (at least 6 days)
- Period " rivaroxaban alone"
- Washout period (at least 6 days)
- Period " " rivaroxaban and activated charcoal 8 hours after rivaroxaban administration"
Intervention: rivaroxaban and activated charcoal (Drug)
Arm C
. Period " rivaroxaban and activated charcoal 2 hours after rivaroxaban administration"
- Washout period (at least 6 days)
- Period " " rivaroxaban and activated charcoal 8 hours after rivaroxaban administration"
- Washout period (at least 6 days)
- Period " rivaroxaban alone"
Intervention: rivaroxaban (Drug)
Arm C
. Period " rivaroxaban and activated charcoal 2 hours after rivaroxaban administration"
- Washout period (at least 6 days)
- Period " " rivaroxaban and activated charcoal 8 hours after rivaroxaban administration"
- Washout period (at least 6 days)
- Period " rivaroxaban alone"
Intervention: rivaroxaban and activated charcoal (Drug)
Outcomes
Primary Outcomes
plasma concentrations of rivaroxaban
Time Frame: H0.5, H0.75, H1, H1.5, H2, H2.5, H3, H4, H5, H6, H8, H10, H12, H14, H18 and H24 after rivaroxaban administration
rivaroxaban pharmacokinetics
Secondary Outcomes
No secondary outcomes reported