Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder

Study Overview
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Brief Summary
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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

Official Title
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Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder

Conditions
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Thromboembolism

Intervention / Treatment
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* Drug: Apixaban


Participation Criteria
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Eligibility Criteria
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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])

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Apixaban (low dose)<br> | Drug: Apixaban<br>* Specified dose on specified days<br>* Other names: BMS-562247;|
| Experimental: Group 2A: Apixaban (low dose)<br> | Drug: Apixaban<br>* Specified dose on specified days<br>* Other names: BMS-562247;|
| Experimental: Group 2B: Apixaban (low dose)<br> | Drug: Apixaban<br>* Specified dose on specified days<br>* Other names: BMS-562247;|
| Experimental: Group 3: Apixaban (low dose)<br> | Drug: Apixaban<br>* Specified dose on specified days<br>* Other names: BMS-562247;|
| Experimental: Group 4: Apixaban (low dose)<br> | Drug: Apixaban<br>* Specified dose on specified days<br>* Other names: BMS-562247;|
| Experimental: Group 5: Apixaban (low dose)<br> | Drug: Apixaban<br>* Specified dose on specified days<br>* Other names: BMS-562247;|
| Experimental: Group 2A (higher dose): Apixaban (low dose)<br> | Drug: Apixaban<br>* Specified dose on specified days<br>* Other names: BMS-562247;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events (AEs) | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Number of participants with Serious Adverse Events (SAEs) | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Change from baseline in Vital Signs of body temperature | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Change from baseline in Vital Signs of respiratory rate | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Change from baseline in Vital Signs of blood pressure | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Change from baseline in Vital Signs of heart rate | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Number of participants with abnormalities in Physical Examinations | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Change from baseline in Clinical Laboratory Tests of blood | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Change from baseline in Clinical Laboratory Tests of blood serum | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Change from baseline in International Normalized Ratio (INR) clotting activity during treatment | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Change from baseline in Prothrombin Time (PT) clotting activity during treatment | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Change from baseline in Clinical Laboratory Tests of urine | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing | 
| Pharmacodynamics will be analyzed using anti-Factor Xa activity |  | Up to 26 hours, post dose (from Day 1 to Day 2) |