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

• Register: EUCTR
• Last refreshed on: 18 June 2018
• Main ID: EUCTR2015-000962-76-SE
• Date of registration: 21/08/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer AG
• Public title: 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
• Scientific title: Single-dose study testing a rivaroxaban dry powder formulation for oral suspension in children from 6 months to 12 years with previous thrombosis - Phase 1 granules for oral suspension
• Date of first enrolment: 11/11/2015
• Target sample size: 48
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000962-76
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Finland, France, Hungary, Ireland, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Geraldine Chaikin
• Affiliation: Bayer AG

• Name: Geraldine Chaikin
• Affiliation: Bayer AG

Key inclusion & exclusion criteria

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
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Thrombosis
MedDRA version: 19.0 Level: PT Classification code 10043607 Term: Thrombosis System Organ Class: 10047065 - Vascular disorders

Intervention(s)

Product Name: xarelto
Product Code: BAY59-7939
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Current Sponsor code: BAY59-7939
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

Main Objective: • To characterize the pharmacokinetic profile of rivaroxaban administered as dry powder for suspension

Timepoint(s) of evaluation of this end point: Depending on age, PK samples are collected at several time points within 24 hours after drug administration

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.

Secondary Objective: • To document safety and tolerability in terms of AEs observed after administration of the rivaroxaban dry powder for suspension formulation

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: At 24 hrs after drug administration with aftive followup for 7 (+3) days.

Secondary end point(s): The principal safety outcome is the composite of major bleeding and clinically relevant non-major bleeding.

Secondary ID(s)

2015-000962-76-AT

17992

Source(s) of Monetary Support

Bayer AG