Single-dose study testing a rivaroxaban dry powder to be diluted into an oral suspension in children from 6 months to 12 years with previous blood clot

Phase 1

Conditions: Thrombosis
MedDRA version: 18.1Level: PTClassification code 10043607Term: ThrombosisSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2015-000962-76-HU

Lead Sponsor: Bayer Health Care AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

1.Children with an age between 6 months and <12 years who
have completed anticoagulant treatment at least 10 days prior
to the planned study drug administration
2. Normal prothrombin time (PT) and activated partial
thromboplastin time (aPTT) within 10 days prior to planned
study drug administration
3. Written informed consent provided and, if applicable, child
assent provided
Are the trial subjects under 18? yes
Number of subjects for this age range: 48
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Active bleeding or high risk for bleeding, contraindicating
anticoagulant therapy
2. Planned invasive procedures, including removal of central
lines, within 24 hours before and after single dose intake
3. An estimate glomerular filtration rate (eGFR)
< 30 mL/min/1.73m2 calculated according to Cockcroft-Gault
formula
4. Hepatic disease which is associated either with: coagulopathy
leading to a clinically relevant bleeding risk, or alanine
aminotransferase (ALT) > 5x upper limit of normal (ULN), or
total bilirubin > 2x ULN with direct bilirubin > 20% of the
total
5. Platelet count < 50 x 109/L
6. Hypertension defined as systolic and/or diastolic blood
pressure >95th percentile for age)
7. Concomitant use of strong inhibitors of both CYP3A4 and
P-glycoprotein, e.g., all human immunodeficiency virus
protease inhibitors and the following azole-antimycotic
agents: ketoconazole, itraconazole, voriconazole, and
posaconazole, if used systemically (fluconazole is allowed)
8. Concomitant use of strong inducers of CYP3A4, e.g.,
rifampicin, rifabutin, phenobarbital, phenytoin and
carbamazepine
9. Inability to cooperate with the study procedures
10. Hypersensitivity to rivaroxaban
11. Participation in a study with an investigational drug other than
rivaroxaban or a medical device within 30 days prior to
treatment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To characterize the pharmacokinetic profile of rivaroxaban administered as dry powder for suspension;Secondary Objective: •To document safety and tolerability in terms of AEs observed after administration of the rivaroxaban dry powder for suspension formulation;Primary end point(s): The primary variables for pharmacokinetics will be the standard pharmacokinetic (PK) parameters for exposure, area under the curve (AUC) and Cmax, derived via population PK approaches. ;Timepoint(s) of evaluation of this end point: Depending on age, PK samples are collected at several time points within<br>24 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The principal safety outcome is the composite of major bleeding and clinically relevant non-major bleeding.;Timepoint(s) of evaluation of this end point: At 24 hrs after drug administration with aftive followup for 7 (+3) days.