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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367027
• Other study ID #: 17769
• Secondary ID: 2014-004337-69
• Status: Completed
• Phase: Phase 1
• First received: February 13, 2015
• Last updated: June 9, 2015
• Start date: February 2015
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Single dose of 10 mg oral suspension (dry powder) in fasted conditions.
• Rivaroxaban (Xarelto, BAY59-7939)
Single dose of 20 mg oral suspension (dry powder) in fed conditions.
• Rivaroxaban (Xarelto, BAY59-7939)
Single dose of 10 mg oral suspension in fasted conditions.
• Rivaroxaban (Xarelto, BAY59-7939)
Single dose of 10 mg tablet in fasted conditions.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of rivaroxaban characterized by AUC	AUC:area under the concentration vs. time curve from zero to infinity after single (first) dose	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)	No
Primary	Plasma concentration of rivaroxaban characterized by AUC/D	AUC/D: AUC divided by dose	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)	No
Primary	Plasma concentration of rivaroxaban characterized by Cmax	Cmax: maximum drug concentration in plasma after single dose administration	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)	No
Primary	Plasma concentration of rivaroxaban characterized by Cmax/D	Cmax/D: Cmax divided by dose	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)	No

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