Thromboembolism
Conditions
Brief summary
CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis
Interventions
DRUGApixaban
Specified dose on specified days
Sponsors
Pfizer
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder * Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to \<18 years of age * Gestational and post-conceptual age will only be taken into consideration for eligibility up to 6 months of age * Neonates: defined as newly born (within 4 weeks) * Participants with any functional CVAD (Central Venous Access Device) in the upper or lower venous system
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 * Inability to tolerate oral medication or administration of oral medication via an enteral tube (nasogastric tube \[NG tube\] or gastronomy tube \[G-tube\])
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban | Up to 26 hours, post dose (from Day 1 to Day 2) |
| Maximum estimated plasma concentration (Cmax) of Apixaban | Up to 26 hours, post dose (from Day 1 to Day 2) |
| Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban | Up to 26 hours, post dose (from Day 1 to Day 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Vital Signs of respiratory rate | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
| Change from baseline in Vital Signs of blood pressure | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
| Change from baseline in Vital Signs of heart rate | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
| Number of participants with abnormalities in Physical Examinations | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
| Change from baseline in Clinical Laboratory Tests of blood | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
| Number of participants with Adverse Events (AEs) | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
| Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
| Change from baseline in International Normalized Ratio (INR) clotting activity during treatment | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
| Change from baseline in Prothrombin Time (PT) clotting activity during treatment | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
| Change from baseline in Clinical Laboratory Tests of urine | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
| Pharmacodynamics will be analyzed using anti-Factor Xa activity | Up to 26 hours, post dose (from Day 1 to Day 2) | — |
| Change from baseline in Clinical Laboratory Tests of blood serum | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
| Number of participants with Serious Adverse Events (SAEs) | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
| Change from baseline in Vital Signs of body temperature | Up to 30 Days after last dosing | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing |
Countries
Australia, Canada, Israel, Mexico, United States
Outcome results
None listed