check_circleStudy Completed

Pharmacokinetics

Bayer Identifier:

17769

ClinicalTrials.gov Identifier:

NCT02367027

EudraCT Number:

2014-004337-69

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 55 Years
  • - 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.

  • - 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
    - 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 summary

Enrollment Goal
18
Trial Dates
February 2015 - June 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Mannheim GmbHMannheim, 68167, Germany

Primary Outcome

  • Plasma concentration of rivaroxaban characterized by AUC
    AUC:area under the concentration vs. time curve from zero to infinity after single (first) dose
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of rivaroxaban characterized by AUC/D
    AUC/D: AUC divided by dose
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of rivaroxaban characterized by Cmax
    Cmax: maximum drug concentration in plasma after single dose administration
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of rivaroxaban characterized by Cmax/D
    Cmax/D: Cmax divided by dose
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
4

Additional Information

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