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

This study is not yet open for participant recruitment.
Verified November 2012 by Bristol-Myers Squibb
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01707394
First received: October 12, 2012
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Thromboembolism
 Drug: Apixaban
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:

Drug Information available for: Apixaban
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ] [ Designated as safety issue: No ]
  • Maximum estimated plasma concentration (Cmax) of Apixaban [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ] [ Designated as safety issue: No ]
  • Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety is measured by adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests [ Time Frame: Up to 30 Days after last dosing ] [ Designated as safety issue: Yes ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  • Pharmacodynamics will be measured by anti-Factor Xa confirmed by analysis of anti-Factor Xa [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Apixaban (low dose)

Apixaban solution 0.21 mg/m2 by mouth single dose for 1 day

  • Group 1: Neonates up to 27 days of age
 Drug: Apixaban
Other Name: BMS-562247
Experimental: Group 2: Apixaban (low dose)

Apixaban solution 1.08 mg/ m2 by mouth single dose for 1 day

  • Group 2: ≥ 28 days to < 2 years
 Drug: Apixaban
Other Name: BMS-562247
Experimental: Group 3: Apixaban (low dose)

Apixaban solution 1.17 mg/ m2 by mouth single dose for 1 day

  • Group 3: 2 years to < 6 years
 Drug: Apixaban
Other Name: BMS-562247
Experimental: Group 4: Apixaban (low dose)

Apixaban solution 1.80 mg/ m2 by mouth single dose for 1 day

  • Group 4: 6 years to <12 years
 Drug: Apixaban
Other Name: BMS-562247
Experimental: Group 5: Apixaban (low dose)

Apixaban solution 2.19 mg/ m2 by mouth single dose for 1 day

  • Group 5: 12 years to <18 years
 Drug: Apixaban
Other Name: BMS-562247

  Eligibility

Ages Eligible for Study:   37 Weeks to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with chronic stable disease that are at risk for a venous or arterial thrombotic Neonates > 37 weeks gestation at birth to < 18 years of age

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707394

Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01707394     History of Changes
Other Study ID Numbers: CV185-118, 2012-001581-15
Study First Received: October 12, 2012
Last Updated: November 22, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Thromboembolism
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013