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

NCT ID: NCT02367027

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-06-30

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Arm 1 - BAY59-7939

10 mg oral suspension (dry powder) in fasted conditions

Group Type: EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

Single dose of 10 mg oral suspension (dry powder) in fasted conditions.

Arn 2 - BAY59-7939

20 mg oral suspension (dry powder) in fed conditions.

Group Type: EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

Single dose of 20 mg oral suspension (dry powder) in fed conditions.

Arm 3 - BAY59-7939

10 mg oral suspension in fasted conditions

Group Type: EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

Single dose of 10 mg oral suspension in fasted conditions.

Arm 4 - BAY59-7939

10 mg tablet in fasted conditions.

Group Type: EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

Single dose of 10 mg tablet in fasted conditions.

Interventions

Rivaroxaban (Xarelto, BAY59-7939)

Single dose of 10 mg oral suspension (dry powder) in fasted conditions.

Intervention Type: DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Single dose of 20 mg oral suspension (dry powder) in fed conditions.

Intervention Type: DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Single dose of 10 mg oral suspension in fasted conditions.

Intervention Type: DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Single dose of 10 mg tablet in fasted conditions.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Mannheim, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

2014-004337-69

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17769

Identifier Type: -

Identifier Source: org_study_id