HealthyPhase 1RICHAR2NCT04767776
Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics.
A Phase 1 study testing Rivaroxaban and Activated charcoal in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rivaroxaban and Activated charcoal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2022to 4 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Contra-indication to rivaroxaban
- Contra-indication to activated charcoal
- With a history of hemorrhagic disease
- Smoker
- Organic lesion likely to bleed
- Severe liver disease
Show all 15Show fewer
- 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 ...)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Rivaroxaban, Activated charcoal
- Keywords
- Rivaroxaban,, Activated charcoal, Pharmacokinetics, Poisoning
- Medical subject headings
- Anthrax, Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
rivaroxaban 40 mg/day (1 day).
Activated charcoalDrug
Activated charcoal 2 hours after rivaroxaban administration (1 day).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: Rivaroxaban; Drug: Activated charcoal |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentrations of rivaroxaban
rivaroxaban pharmacokinetics
Measured: 1, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 24 hours after rivaroxaban administration
Secondary outcomes (1)
Adverse events
Analysis adverse events related to the administration of treatment.
Measured: 24 hour after rivaroxaban administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start3 Jan 2022
- Primary completion26 Sep 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick MISMETTI, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767776
- Sponsor's protocol ID
- 18CH050
- Other IDs
- 2019-004425-25, 2019
- Acronym
- RICHAR2
- Status last verified
- Dec 2022
- First submitted
- 19 Feb 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics.
- ClinicalTrials.gov ID
- NCT04767776
- Acronym / sponsor ID
- RICHAR2 / 18CH050
- Conditions
- Healthy
- Keywords
- Rivaroxaban,, Activated charcoal, Pharmacokinetics, Poisoning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Rivaroxaban, Drug: Activated charcoal* 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) |
| Arm B | Experimental | Drug: Rivaroxaban, Drug: Activated charcoal* 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) |
| Arm C | Experimental | Drug: Rivaroxaban, Drug: Activated charcoal* 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) |
| Arm D | Experimental | Drug: Rivaroxaban, Drug: Activated charcoal* 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) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- Contra-indication to rivaroxaban
- Contra-indication to activated charcoal
- With a history of hemorrhagic disease
- Smoker
- Organic lesion likely to bleed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxabanrivaroxaban 40 mg/day (1 day). | Drug | Arm A, Arm B, Arm C, Arm D |
| Activated charcoalActivated charcoal 2 hours after rivaroxaban administration (1 day). | Drug | Arm A, Arm B, Arm C, Arm D |
Primary outcome
plasma concentrations of rivaroxaban
Time frame: 1, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 24 hours after rivaroxaban administration
rivaroxaban pharmacokinetics
1 secondary outcome
Adverse events
Time frame: 24 hour after rivaroxaban administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick MISMETTI, MD PhD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rivaroxaban and Activated charcoal in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma concentrations of rivaroxaban (time frame: 1, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 24 hours after rivaroxaban administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.