Clinical trial NCT01707394: Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thromboembolism
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2012-10-16
Enrollment: 49
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility 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 \[G-tube\])

Primary outcomes:
measure: Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban
timeFrame: Up to 26 hours, post dose (from Day 1 to Day 2)
measure: Maximum estimated plasma concentration (Cmax) of Apixaban
timeFrame: Up to 26 hours, post dose (from Day 1 to Day 2)
measure: Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban
timeFrame: Up to 26 hours, post dose (from Day 1 to Day 2)
Secondary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 30 Days after last dosing
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to 30 Days after last dosing
measure: Change from baseline in Vital Signs of body temperature
timeFrame: Up to 30 Days after last dosing
measure: Change from baseline in Vital Signs of respiratory rate
timeFrame: Up to 30 Days after last dosing
measure: Change from baseline in Vital Signs of blood pressure
timeFrame: Up to 30 Days after last dosing
measure: Change from baseline in Vital Signs of heart rate
timeFrame: Up to 30 Days after last dosing
measure: Number of participants with abnormalities in Physical Examinations
timeFrame: Up to 30 Days after last dosing
measure: Change from baseline in Clinical Laboratory Tests of blood
timeFrame: Up to 30 Days after last dosing
measure: Change from baseline in Clinical Laboratory Tests of blood serum
timeFrame: Up to 30 Days after last dosing
measure: Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment
timeFrame: Up to 30 Days after last dosing
measure: Change from baseline in International Normalized Ratio (INR) clotting activity during treatment
timeFrame: Up to 30 Days after last dosing
measure: Change from baseline in Prothrombin Time (PT) clotting activity during treatment
timeFrame: Up to 30 Days after last dosing
measure: Change from baseline in Clinical Laboratory Tests of urine
timeFrame: Up to 30 Days after last dosing
measure: Pharmacodynamics will be analyzed using anti-Factor Xa activity
timeFrame: Up to 26 hours, post dose (from Day 1 to Day 2)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children'S Hospital
state: Arkansas
city: Orange
country: United States
facility: Children'S Hospital Of Orange County
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Childrens National Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Children's Healthcare Of Atlanta
state: Georgia
city: Des Moines
country: United States
facility: Blank Childrens Hospital
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: Kosair Charities Pediatric Clinical Research Unit
state: Kentucky
city: Kansas City
country: United States
facility: Children'S Mercy Hospital And Clinics
state: Missouri
city: New Brunswick
country: United States
facility: Saint Peter'S University Hospital
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Toledo
country: United States
facility: ProMedica Toledo Children's Hospital
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Children'S Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Childrens Hospital Of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hopsital Of Pittsburgh Of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital Of Pittsburgh Of UPMC
state: Pennsylvania
city: Milwaukee
country: United States
facility: Childrens Hospital Of Wisconsin
state: Wisconsin
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: Edmonton
country: Canada
facility: University of Alberta - Edmonton Clinic Health Academy
state: Alberta
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: The Hospital For Sick Children
state: Ontario
city: Ramat Gan
country: Israel
facility: Local Institution
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: