Study to evaluate a single dose of Apixaban in Pediatric Subjects at Risk for a Thrombotic Disorder
- Conditions
- MedDRA version: 18.0Level: LLTClassification code 10043566Term: ThromboembolismSystem Organ Class: 100000004866ThromboembolismTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-001581-15-Outside-EU/EEA
- Lead Sponsor
- Bristol-Myers Squibb Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
Subjects with any stable disease that are at risk for a venous or arterial thrombotic disorder.
Neonates > 37 weeks gestation at birth to <18 years of age.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
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
• Current or recent (within 3 months of study drug administration) gastrointestinal disease or gastrointestinal surgery that, in the opinion of the investigator and the BMS Medical Monitor, could impact the absorption of the study drug.
• Active bleeding or high risk of bleeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: CV185118 is a single dose Apixaban PK/PD study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects at risk for thrombosis.;Secondary Objective: To assess the single dose safety and tolerability of apixaban in pediatric subjects.<br>To assess the single dose anti-factor Xa activity in pediatric subjects.;Primary end point(s): • Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban<br>• Maximum estimated plasma concentration (Cmax) of Apixaban<br>• Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban;Timepoint(s) of evaluation of this end point: Days 1 and 2
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Safety is measured by adverse event reports and the results of vital sign measurements, physical examinations, and clinical laboratory tests.<br>•Pharmacodynamics will be measured by anti-Factor Xa confirmed by analysis of anti-Factor Xa.;Timepoint(s) of evaluation of this end point: • Safety: From Day 1, up to 30 Days after last dosing.<br>• Anti-Factor Xa: Days 1 and 2.