PharmacokineticsPhase 1NCT02367027
Relative Bioavailability Study in Healthy Subjects Comparing 2 Dry Powder Oral Suspensions of Rivaroxaban Under Fasting and 20 mg of an Oral Suspension of Rivaroxaban Under Fed Conditions to 10 mg of an Immediate Release Tablet Under Fasting Conditions
A Phase 1 study testing Rivaroxaban (Xarelto, BAY59-7939) in people with Pharmacokinetics, run by Bayer at 1 site in Germany.
Trial summary
Rivaroxaban is a substance developed for use in the treatment of blood coagulation disorders.Thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood vessels. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Jun 2015
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
- Age: 18 to 55 years (inclusive) at the first screening examination
- White
- Body Mass Index (BMI): ≥18.0 and ≤29.9 kg/m2 at the screening visit.
Who cannot join
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Known coagulation disorders (e.g. von Willebrand's disease, hemophilia)
- Known disorders with increased bleeding risk (e.g. periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
- Known sensitivity to common causes of bleeding (e.g. nasal)
- Regular use of medicines and use of medication that may have an impact on the study objectives
- Clinically relevant findings in the ECG such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTc-interval over 450 msec
Show all 9Show fewer
- Clinically relevant findings in the physical examination
- Clinically relevant deviations of the screened laboratory parameters from reference ranges
- Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-dose, Open-label, Randomized, 4-way Crossover Study to Compare a Dry Powder Oral Suspension (10 mg and 20 mg Dose of Rivaroxaban) With an Oral Suspension (10 mg of Rivaroxaban) and 10 mg of an Immediate Release Tablet Under Fasting Conditions (10 mg Doses) and Under Fed Conditions (20 mg Dose) in Healthy Male Subjects
Rivaroxaban is a substance developed for use in the treatment of blood coagulation disorders.Thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood vessels. Excessive coagulation activity can occur in children as well, and rivaroxaban is therefore being developed for the treatment of thromboembolic events in children and adolescents. As small children are often unable to swallow tablets, an oral suspension (mixture of a liquid containing finely distributed solids) has been developed which allows dosing according to body weight.The objective of this trial is to compare the bioavailability (proportion of a substance that remains available unchanged in the blood circulation) of a new oral suspension of rivaroxaban with a previously used oral suspension and with a rivaroxaban tablet approved for treatment. In order to evaluate the potential influence of food, the new oral suspension containing 20 mg rivaroxaban will be taken after consuming food. In addition, the pharmacokinetics (concentrations of the drug and breakdown products (metabolites) in blood), safety and tolerability will be assessed.
- Conditions
- Pharmacokinetics
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939)
- Keywords
- Biological Availability, Relative Bioavailability Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Single dose of 10 mg oral suspension (dry powder) in fasted conditions.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Single dose of 20 mg oral suspension (dry powder) in fed conditions.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Single dose of 10 mg oral suspension in fasted conditions.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Single dose of 10 mg tablet in fasted conditions.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - BAY59-7939 | Experimental | 10 mg oral suspension (dry powder) in fasted conditions Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
| Arn 2 - BAY59-7939 | Experimental | 20 mg oral suspension (dry powder) in fed conditions. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
| Arm 3 - BAY59-7939 | Experimental | 10 mg oral suspension in fasted conditions Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
| Arm 4 - BAY59-7939 | Experimental | 10 mg tablet in fasted conditions. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of rivaroxaban characterized by AUC
AUC:area under the concentration vs. time curve from zero to infinity after single (first) dose
Measured: Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours), at 48 hr after administration), at 72 hr after administration)
Plasma concentration of rivaroxaban characterized by AUC/D
AUC/D: AUC divided by dose
Measured: Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours),at 48 hr after administration),at 72 hr after administration)
Plasma concentration of rivaroxaban characterized by Cmax
Cmax: maximum drug concentration in plasma after single dose administration
Measured: Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours),at 48 hr after administration),at 72 hr after administration)
Plasma concentration of rivaroxaban characterized by Cmax/D
Cmax/D: Cmax divided by dose
Measured: Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours),at 48 hr after administration),at 72 hr after administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367027
- Sponsor's protocol ID
- 17769
- Other IDs
- 2014-004337-69, 2014
- Status last verified
- Jun 2015
- First submitted
- 13 Feb 2015
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose, Open-label, Randomized, 4-way Crossover Study to Compare a Dry Powder Oral Suspension (10 mg and 20 mg Dose of Rivaroxaban) With an Oral Suspension (10 mg of Rivaroxaban) and 10 mg of an Immediate Release Tablet Under Fasting Conditions (10 mg Doses) and Under Fed Conditions (20 mg Dose) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02367027
- Acronym / sponsor ID
- 17769
- Conditions
- Pharmacokinetics
- Keywords
- Biological Availability, Relative Bioavailability Trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Feb 2015 (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 substance developed for use in the treatment of blood coagulation disorders.Thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood vessels. Excessive coagulation activity can occur in children as well, and rivaroxaban is therefore being developed for the treatment of thromboembolic events in children and adolescents. As small children are often unable to swallow tablets, an oral suspension (mixture of a liquid containing finely distributed solids) has been developed which allows dosing according to body weight.The objective of this trial is to compare the bioavailability (proportion of a substance that remains available unchanged in the blood circulation) of a new oral suspension of rivaroxaban with a previously used oral suspension and with a rivaroxaban tablet approved for treatment. In order to evaluate the potential influence of food, the new oral suspension containing 20 mg rivaroxaban will be taken after consuming food. In addition, the pharmacokinetics (concentrations of the drug and breakdown products (metabolites) in blood), safety and tolerability will be assessed.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - BAY59-7939 | Experimental | Drug: Rivaroxaban (Xarelto, BAY59-7939)10 mg oral suspension (dry powder) in fasted conditions |
| Arn 2 - BAY59-7939 | Experimental | Drug: Rivaroxaban (Xarelto, BAY59-7939)20 mg oral suspension (dry powder) in fed conditions. |
| Arm 3 - BAY59-7939 | Experimental | Drug: Rivaroxaban (Xarelto, BAY59-7939)10 mg oral suspension in fasted conditions |
| Arm 4 - BAY59-7939 | Experimental | Drug: Rivaroxaban (Xarelto, BAY59-7939)10 mg tablet in fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects
- Age: 18 to 55 years (inclusive) at the first screening examination
- White
- Body Mass Index (BMI): ≥18.0 and ≤29.9 kg/m2 at the screening visit.
Key exclusion criteria (9 listed)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Known coagulation disorders (e.g. von Willebrand's disease, hemophilia)
- Known disorders with increased bleeding risk (e.g. periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
- Known sensitivity to common causes of bleeding (e.g. nasal)
- Regular use of medicines and use of medication that may have an impact on the study objectives
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 |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)Single dose of 10 mg oral suspension (dry powder) in fasted conditions. | Drug | Arm 1 - BAY59-7939 |
| Rivaroxaban (Xarelto, BAY59-7939)Single dose of 20 mg oral suspension (dry powder) in fed conditions. | Drug | Arn 2 - BAY59-7939 |
| Rivaroxaban (Xarelto, BAY59-7939)Single dose of 10 mg oral suspension in fasted conditions. | Drug | Arm 3 - BAY59-7939 |
| Rivaroxaban (Xarelto, BAY59-7939)Single dose of 10 mg tablet in fasted conditions. | Drug | Arm 4 - BAY59-7939 |
Primary outcome
Plasma concentration of rivaroxaban characterized by AUC
Time frame: Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours), at 48 hr after administration), at 72 hr after administration)
AUC:area under the concentration vs. time curve from zero to infinity after single (first) dose
Plasma concentration of rivaroxaban characterized by AUC/D
Time frame: Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours),at 48 hr after administration),at 72 hr after administration)
AUC/D: AUC divided by dose
Plasma concentration of rivaroxaban characterized by Cmax
Time frame: Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours),at 48 hr after administration),at 72 hr after administration)
Cmax: maximum drug concentration in plasma after single dose administration
Plasma concentration of rivaroxaban characterized by Cmax/D
Time frame: Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours),at 48 hr after administration),at 72 hr after administration)
Cmax/D: Cmax divided by dose
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 10 Jun 2015.
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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.
Bayer Study Director study director
Bayer
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 (Xarelto, BAY59-7939) in people with Pharmacokinetics, run by Bayer at 1 site in Germany.
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 4 inclusion and 9 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 10 Jun 2015. 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 Germany. 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 concentration of rivaroxaban characterized by AUC (time frame: Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours), at 48 hr after administration), at 72 hr after administration)). The study lists 4 primary outcomes in all. 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 10 Jun 2015.