Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• Pediatric subjects > 6 months and < 18 years of age at the time of administration of study drug.

• Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE

Exclusion Criteria:

• Any major or clinically relevant bleeding during prior VTE treatment

• Abnormal coagulation tests within 7 days prior to study drug administration

• Severe renal impairment

• Planned invasive procedures prior to or after 24 hours of study drug administration