HealthyPhase 1RICHARNCT02657512
Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects
A Phase 1 study testing rivaroxaban and 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. Few results are available on the use of activated charcoal in rivaroxaban 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 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
- Jan 2016to Apr 2016
- 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 genetic consent form
- BMI between 18.5 and 25
- normal clinical exam
- normal biological exam
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects : RICHAR 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. 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.
- Conditions
- Healthy
- Being tested
- rivaroxaban, rivaroxaban and activated charcoal
- Keywords
- Rivaroxaban, pharmacokinetics, activated charcoal, 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)
rivaroxaban and activated charcoalDrug
rivaroxaban 40 mg/day (1 day) and 50 g of activated charcoal 2 or 5 or 8 hours after rivaroxaban administration (1 day)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | * 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" Receives: Drug: rivaroxaban; Drug: rivaroxaban and activated charcoal |
| Arm B | Experimental | . 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" Receives: Drug: rivaroxaban; Drug: rivaroxaban and activated charcoal |
| Arm C | Experimental | . 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" Receives: Drug: rivaroxaban; Drug: rivaroxaban and 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: H0.5, H0.75, H1, H1.5, H2, H2.5, H3, H4, H5, H6, H8, H10, H12, H14, H18 and H24 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 posted18 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 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
- NCT02657512
- Sponsor's protocol ID
- 1508030
- Other IDs
- 2015-001839-21, 140096A-21, 2015
- Acronym
- RICHAR
- Status last verified
- May 2016
- First submitted
- 14 Jan 2016
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ollier E, Hodin S, Lanoiselee J, Escal J, Accassat S, De Magalhaes E, Basset T, Bertoletti L, Mismetti P, Delavenne X. Effect of Activated Charcoal on Rivaroxaban Complex Absorption. Clin Pharmacokinet. 2017 Jul;56(7):793-801. doi: 10.1007/s40262-016-0485-1.
PubMed 27910037
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects : RICHAR Study
- ClinicalTrials.gov ID
- NCT02657512
- Acronym / sponsor ID
- RICHAR / 1508030
- Conditions
- Healthy
- Keywords
- Rivaroxaban, pharmacokinetics, activated charcoal, 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
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Jan 2016 (estimated)
- 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. 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: rivaroxaban, Drug: rivaroxaban and activated charcoal* 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" |
| Arm B | Experimental | Drug: rivaroxaban, Drug: rivaroxaban and activated charcoal. 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" |
| Arm C | Experimental | Drug: rivaroxaban, Drug: rivaroxaban and activated charcoal. 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" |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
| rivaroxaban and activated charcoalrivaroxaban 40 mg/day (1 day) and 50 g of activated charcoal 2 or 5 or 8 hours after rivaroxaban administration (1 day) | Drug | Arm A, Arm B, Arm C |
Primary outcome
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
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 25 May 2016.
- Derived from this study: PubMed 27910037Ollier E, Hodin S, Lanoiselee J, Escal J, Accassat S, De Magalhaes E, Basset T, Bertoletti L, Mismetti P, Delavenne X. Effect of Activated Charcoal on Rivaroxaban Complex Absorption. Clin Pharmacokinet. 2017 Jul;56(7):793-801. doi: 10.1007/s40262-016-0485-1.
- 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 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 6 inclusion and 7 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 25 May 2016. 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: H0.5, H0.75, H1, H1.5, H2, H2.5, H3, H4, H5, H6, H8, H10, H12, H14, H18 and H24 after rivaroxaban administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657512, which also lists 1 linked publication.
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 25 May 2016.