Health Status
Item
Healthy subjects with no clinically significant abnormality identified by physician by evaluation of medical history, physical examination, clinical laboratory tests or electrocardiogram (ECG).
boolean
C0018759 (UMLS CUI [1])
Gender, Age
Item
Male and female subjects between the ages of 18 to 64, inclusive.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Pregnancy, Breast Feeding
Item
A female subject is eligible to participate if she is neither pregnant nor lactating, and falls into one of the following categories: • non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophorectomy, or post-menopausal females defined as being amenorrheic for greater than 1 year and having estradiol and FSH levels consistent with menopause • child-bearing potential with negative βhCG test and agrees to comply with recognized non- hormonal contraceptive methods from screening or at least two weeks prior to first dose (whichever is earlier) until the follow-up visit. Recognized non-hormonal contraceptive methods include: complete abstinence from intercourse, two forms of barrier contraception (e.g. condom with spermicide, or diaphragm with spermicide), or intrauterine device (IUD).
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Body Weight
Item
Body Weight > 50 kg for males and > 45 kg for females.
boolean
C0005910 (UMLS CUI [1])
Body mass index
Item
Body Mass Index (BMI) in the range of 19 - 30 kg/m2 BMI = weight [kg]/(height [m]) 2
boolean
C1305855 (UMLS CUI [1])
Comprehension, Study Protocol; Protocol Compliance
Item
Subject is able to understand and comply with the protocol requirements, instructions and restrictions.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Informed Consent
Item
Capable of giving written informed consent.
boolean
C0021430 (UMLS CUI [1])
Abnormality, Clinically Significant Indicator
Item
Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, 12-lead electrocardiogram (ECG).
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Gilbert Disease (disorder), Medical History
Item
History of Gilbert's syndrome.
boolean
C0017551 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Deep Vein Thrombosis, Thromboembolism, Medical History
Item
Any previous history of deep vein thrombosis or any other thromboembolic event.
boolean
C0149871 (UMLS CUI [1,1])
C0040038 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Heparin, Hypersensitivity; Heparin-induced thrombocytopenia
Item
History of sensitivity to heparin, or heparin-induced thrombocytopenia.
boolean
C0019134 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0272285 (UMLS CUI [1,3])
Experimental Drug, Hypersensitivity
Item
History of sensitivity to any of the study medications, or components thereof.
boolean
C0304229 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Myocardial Infarction, Cerebrovascular Event, Sudden Death, Family History
Item
History of myocardial infarction, stroke, or sudden death in a first degree family member at age of < 60 years.
boolean
C0027051 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0011071 (UMLS CUI [1,3])
C0241889 (UMLS CUI [1,4])
Thrombocytopenia; Hemorrhage, Platelet count abnormal; Hemorrhage, Platelet function, Abnormal
Item
History of thrombocytopenia or bleeding due to abnormal platelet number or function.
boolean
C0040034 (UMLS CUI [1])
C0019080 (UMLS CUI [2,1])
C0580317 (UMLS CUI [2,2])
C0019080 (UMLS CUI [3,1])
C1254881 (UMLS CUI [3,2])
C0205161 (UMLS CUI [3,3])
Platelet Clumps
Item
History of platelet clumping that prevents reliable measurement of platelet counts.
boolean
C0427569 (UMLS CUI [1])
Atrial Fibrillation, Mitral Valve Prolapse Syndrome, Heart Murmur, Arterial Bruit
Item
History of atrial fibrillation, mitral valve prolapse, significant heart murmur or vascular bruit.
boolean
C0004238 (UMLS CUI [1,1])
C0026267 (UMLS CUI [1,2])
C0018808 (UMLS CUI [1,3])
C0232112 (UMLS CUI [1,4])
QTcB - Bazett's Correction Formula
Item
Prolonged QTc interval (Bazett's) at screening (for females > 450 msec and for males > 430 msec).
boolean
C1882512 (UMLS CUI [1])
Blood Pressure
Item
Elevated blood pressure at screening (systolic >140 mm Hg, diastolic >85 mm Hg).
boolean
C0005823 (UMLS CUI [1])
Liver Function
Item
Clinically significant liver function tests (LFTs) outside the reference range at screening.
boolean
C0232741 (UMLS CUI [1])
Blood Coagulation Factor, Abnormality
Item
Clotting factor abnormalities associated with hypercoagulability, specifically Factor V Leiden, Protein C or Protein S deficiency or antithrombin III deficiency.
boolean
C0005789 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Hemoglobin measurement, Hematocrit level, Red Blood Cell Count measurement, Reticulocyte count
Item
A hemoglobin, hematocrit, red blood count and/or reticulocyte count outside the normal reference range, and/or clinically significant abnormalities of the remainder of the analytes of the CBC.
boolean
C0518015 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
C0014772 (UMLS CUI [1,3])
C0206161 (UMLS CUI [1,4])
Childbearing Potential, Contraceptive method, Unwilling
Item
Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as described in Protocol Section 5.2.1 Inclusion Criteria.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Beta HCG positive
Item
For female subjects, a positive βhCG at screening or pre-dose in any period.
boolean
C0813152 (UMLS CUI [1])
Hormone replacement therapy
Item
For female subjects, currently receiving hormone replacement therapy (HRT).
boolean
C0282402 (UMLS CUI [1])
Contraceptive methods, Unwilling
Item
Unwillingness of male subjects to abstain from or use a condom during sexual intercourse with pregnant or lactating females; or unwillingness of male subjects to use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until 28 days after the last dose of study medication.
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
HIV Infections , Hepatitis B, Hepatitis C
Item
Positive for HIV, hepatitis B virus or hepatitis C virus assays at screening.
boolean
C0019693 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Urine drug screening
Item
Positive urine drug screen including alcohol at screening or pre-dose.
boolean
C0202274 (UMLS CUI [1])
Substance Use Disoders
Item
History of alcohol/drug abuse or dependence within 12 months of the study.
boolean
C0038586 (UMLS CUI [1])
Alcohol Consumption
Item
History of alcohol consumption in the past six months exceeding 7 units/week for women and 14 units/ week for men (where 1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor).
boolean
C0001948 (UMLS CUI [1])
Cotinine measurement, Tobacco Use, Nicotine
Item
Urinary cotinine levels indicative of smoking at screening or pre-dose. History of regular use of tobacco- or nicotine- containing products within 6 months prior to screening.
boolean
C0202363 (UMLS CUI [1,1])
C0543414 (UMLS CUI [1,2])
C0028040 (UMLS CUI [1,3])
Investigational New Drugs
Item
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
boolean
C0013230 (UMLS CUI [1])
Experimental Drug, Exposure
Item
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
boolean
C0304229 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Pharmaceutic Preparations, Vitamins, Herbal Supplements, Dietary Supplements
Item
Use of prescription or non-prescription drugs (including aspirin and NSAIDs), vitamins, herbal and dietary supplements, or any herbal remedies containing St. John's Wort within 7 days prior to the first dose of study medication. By exception, acetaminophen at doses of < 2g/day, stable thyroid replacement therapy will be allowed.
boolean
C0013227 (UMLS CUI [1,1])
C0042890 (UMLS CUI [1,2])
C1504473 (UMLS CUI [1,3])
C0242295 (UMLS CUI [1,4])
Antacids
Item
Consumption of liquid antacids (e.g. Maalox, Mylanta, Amphogel, Milk of Magnesia) or chewable antacids (e.g. TUMSTM) within 48 hours of the first dose of study medication until the final pharmacokinetic sample of the study has been taken.
boolean
C0003138 (UMLS CUI [1])
Blood Donation, Plasma
Item
Subjects who have donated plasma within 7 days prior to the screening visit or more than 500 mL of blood within 56 days prior to the start of the study.
boolean
C0005794 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])