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Biological AvailabilityPhase 1NCT01853800

Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet

A Phase 1 study testing Rivaroxaban (Xarelto, BAY59-7939) in people with Biological Availability, run by Bayer at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Biological Availability
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
14 participants
Where
1 siteGermany
Study dates
May 2013to Aug 2013
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

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 (eg von Willebrand's disease, hemophilia)
  • Known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
  • Known sensitivity to common causes of bleeding (eg nasal)
  • Regular use of medicines
  • Clinically relevant findings in the ECG (electrocardiogram) 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.

Germany1 site

  • Study site

    Wuppertal, North Rhine-Westphalia, 42096

Other trials in Germany

About this study

Official title: Single-dose, Open-label, Randomized, 4-way Crossover Study to Compare 10 mg of an Oral Suspension of Rivaroxaban Under Fasting (2 Different Batches) and 20 mg of an Oral Suspension of Rivaroxaban Under Fed Conditions to 10 mg of an Immediate Release Tablet Under Fasting Conditions in Healthy 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 rivaroxaban oral solution with that of the rivaroxaban tablet approved for treatment. In order to evaluate the potential influence of food, the 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.

Being tested
Rivaroxaban (Xarelto, BAY59-7939)
Keywords
Relative bioavailability, Rivaroxaban

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

Study groups in NCT01853800
Study groupRoleWhat they receive
Rivaroxaban (Treatment A) suspension (BN03501), fastedExperimentalSubjects received single oral dose of Rivaroxaban suspension 10 mg (Treatment A, Batch number BN03501) under fasting conditions in any intervention period.
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban (Treatment B) suspension (BN03501), fedExperimentalSubjects received single oral dose of Rivaroxaban suspension 20 mg (Treatment B, Batch number BN03501) under fed conditions in any intervention period.
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban (Treatment C) suspension (BR05701), fastedExperimentalSubjects received single oral dose of Rivaroxaban suspension 10 mg (Treatment C, Batch number BR05701) under fasting conditions in any intervention period.
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban (Treatment D) IR tablet, fastedExperimentalSubjects received single oral dose of Rivaroxaban IR tablet 10 mg (Treatment D) under fasting conditions in any intervention period.
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Concentration Versus Time Curve From Zero to Infinity After a Single Dose (AUC)

    Measured: 0-72 hours

  2. Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D)

    Measured: 0-72 hours

  3. Maximum Observed Drug Concentration in Measured Matrix After a Single Dose (Cmax)

    Measured: 0-72 hours

  4. Maximum Observed Drug Concentration in Measured Matrix Divided by Dose (Cmax/D)

    Measured: 0-72 hours

Secondary outcomes (7)

  1. Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Kilogram Body Weight (AUC,norm)

    Measured: 0-72 hours

  2. Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0tlast)]

    Measured: 0-72 hours

  3. Maximum Observed Drug Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm)

    Measured: 0-72 hours

  4. Mean Residence Time (MRT)

    Measured: 0-72 hours

  5. Maximum Observed Drug Concentration Divided by Drug Concentration at 24 hours (Cmax/C24h)

    Measured: 0-72 hours

  6. Time to Reach Maximum Observed Drug Concentration (tmax)

    Measured: 0-72 hours

  7. Terminal Half Life (t1/2)

    Measured: 0-72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionJul 2013
  4. Study completionAug 2013

Resources

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
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01853800
Sponsor's protocol ID
16886
Other IDs
2013-001720-19
Status last verified
Jan 2017
First submitted
13 May 2013
Last updated
23 Jan 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rivaroxaban (Xarelto, BAY59-7939) in people with Biological Availability, 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 2 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 23 Jan 2017. 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?

Area Under the Concentration Versus Time Curve From Zero to Infinity After a Single Dose (AUC) (time frame: 0-72 hours). 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?

On the ClinicalTrials.gov record for NCT01853800.

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 23 Jan 2017.

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