Thrombosis MedDRA version: 17.0 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866
Conditions
Sponsors
Bristol-Myers Squibb Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * For healthy adult subjects: - signed informed consent form - Male or female subjects as determined by no clinically significant deviation from normal in medical history and physical examination - ages 18 to 45 * For pediatric patients: - Parent or legally acceptable representatives must sign informed consent form for all subjects =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * For healthy adult subjects: (1) Medical History and Concurrent Diseases a) Any significant acute or chronic medical illness. b) Any major surgery within 4 weeks of enrollment c) History or evidence of abnormal bleeding or coagulation disorder and/or having a first degree relative coagulation disorder due to genetic defects. d) Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study enrollment. e) Blood transfusion within 4 weeks of study enrollment. f) Inability to be phlebotomized and/or tolerate venous access. g) Recent (within 6 months) drug or alcohol abuse h) Any other sound medical, psychiatric and/or social reason as determined by the investigator. i) Smoking more than 10 cigarettes per day. j) History of positive urine screen for drugs of abuse in the past 6 months. k) PMH of positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV viral RNA or HIV-1, -2 antibody. (2) Physical Findings a) Evidence of excessive bruising, petechia, or organ dysfunction or clinically significant findings that would prevent donation of blood. (3) Prohibited Treatments and/or Therapies a) Exposure to any investigational drug or placebo within 4 weeks of enrollment. b) Use of any other drugs, including over-the-counter medications and herbal preparations, within 1 week prior to study enrollment. c) Currently or within 14 days of blood draw taking any anticoagulants, and thrombolytics (4) Other Exclusion Criteria Prisoners or subjects who are involuntarily incarcerated; Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness * For pediatric patients: (1) Medical History and Concurrent Diseases a) Any significant acute medical illness or a chronic medical illness of leukemia, lymphoma, hepatic impairment, significant renal impairment or severe anemia. b) Subjects known to have prolongation of PT or PTT. c) History of positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV viral RNA or HIV-1, -2 antibody. Pediatric subjects born to HIV, hepatitis B, hepatitis C positive mothers may be included into the study if they test positive on an antibody test, but they are confirmed not HIV, HCV, or HBV infected after been tested according to standard of care guidelines. d) Subjects with cancer on any therapy or subjects in remission treated with chemotherapy < 3 months ago. e) Subjects with known genetic disorders such as hemophilia or thrombophilia or other factor deficiencies. f) History or evidence of abnormal bleeding or coagulation disorder and/or having a first degree relative coagulation disorder due to genetic defects. g) Any major surgery within 4 weeks of study enrollment h) Blood transfusion within 4 weeks of study enrollment. i) Twenty-four hour blood volume loss = 3% of subject’s estimated blood volume. j) Inability to be phlebotomized and/or tolerate venous access. k) Recent (within 6 months) drug or alcohol abuse l) Any other medical, psychiatric and/or social reason as determined by the investigator. m) Smoking more than 10 cigarettes per day. n) History of a significant complicated pregnancy as determined by PI or designee (for women donating umbilical cord blood). o) Pediatric subjects <1 year of age with maternal history of lupus anticoagulant, ITP, or other acquired coagulopathy. (2) Physical Findings a) Evidence of excessive bruising, pet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the in vitro anti-FXa activity of apixaban in pediatric subjects as compared to adult population using Rotachrom chromageneic anti-Xa assay.;Secondary Objective: - To characterize the in vitro anti-FXa activity of apixaban in pediatric populations as ompared to adult population using Diapharma RVV anti-Xa assay. - To characterize modified Prothrombin Time in pediatric populations as compared to adult population. - To characterize Factor X level in pediatric populations as compared to adult population using Diapharma RVV assay.;Primary end point(s): There are no clinical endpoints for this study (In vitro analysis). Pharmacodynamic Endpoint: In vitro analysis of Rotachrom anti-Xa activity, Diapharma factor X level and anti-Xa activity, modified Prothrombin Time, and other exploratory clotting assays or coagulation biomarkers if applicable. Safety assessments will be limited to routine clinical assessment following the blood draw. ;Timepoint(s) of evaluation of this end point: See above, in vitro analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): See above, in vitro analysis.;Timepoint(s) of evaluation of this end point: See above, in vitro analysis. | — |
Countries
United States
Contacts
Public ContactCTT group Manager
Bristol-Myers Squibb Company
Outcome results
None listed