Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children

Inclusion Criteria: * Children with an age ≥2 months and weight between 3 and \<12 kg, who have completed anticoagulant treatment at least 10 days prior to the planned study drug administration. * Gestational age at birth of at least 37 weeks * Oral feeding/ nasogastric/ gastric feeding for at least 10 days * Normal PT and aPTT within 10 days prior to planned study drug administration * Written informed consent provided and, if applicable, child assent provided Exclusion Criteria: * Active bleeding or high risk for bleeding, contraindicating anticoagulant therapy * Planned invasive procedures, including removal of central lines, within 24 hours before and after single dose intake * An estimate glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2 * Hepatic disease which is associated either with: * coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) \> 5x upper level of normal (ULN), or * total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total. * Platelet count \< 50 x 10\^9/L * Hypertension (defined as systolic and/or diastolic blood pressure \>95th percentile for age) * Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, e.g., all human immunodeficiency virus protease inhibitors and the following azoleantimycotic agents: ketoconazole, itraconazole, voriconazole, and posaconazole, if used systemically (fluconazole is allowed) * Concomitant use of strong inducers of CYP3A4, e.g., rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine * Inability to cooperate with the study procedures * Hypersensitivity to rivaroxaban * Participation in a study with an investigational drug other than rivaroxaban or a medical device within 30 days prior to treatment * History of gastrointestinal disease or surgery associated with impaired absorption