Item
Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
Code List
Did the subject meet all the entry criteria?
Males between 18 and 55 years of age, healthy as determined by their medical history, physical examination, laboratory studies, ECGs and other tests
Item
Healthy males between 18 and 55 years of age, inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, ECGs and other tests.
boolean
C0001779 (UMLS CUI [1])
C0086582 (UMLS CUI [2])
C3898900 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0681827 (UMLS CUI [6])
C1623258 (UMLS CUI [7])
C0205394 (UMLS CUI [8])
Body weight and BMI
Item
Body weight > 50 kg (110 lbs) and Body mass index (BMI) between 19 and 34 kg/m2 where: BMI = (weight in kg)/(height in meters)^2
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Negative hepatitis B and C, and HIV tests
Item
Negative hepatitis B and C, and HIV tests.
boolean
C1611173 (UMLS CUI [1])
C1619717 (UMLS CUI [2])
C0481430 (UMLS CUI [3])
Written informed consent and willingness to participate
Item
Willing and able to give written informed consent, willing to participate in the full duration of the study, and able to understand and follow instructions related to study procedures.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Any medical contraindication to participation in the study
Item
Any clinically relevant abnormality identified on the screening or check-in examination/clinical labs or any other medical condition or circumstance making the volunteer unsuitable for participation in the study.
boolean
C2348568 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
Positive urine drug, alcohol or cotinine testing
Item
Positive urine drug, alcohol or cotinine screen at check in or screening visits.
boolean
C0743300 (UMLS CUI [1])
C1699505 (UMLS CUI [2])
C1112219 (UMLS CUI [3])
Recent regular alcohol consumption exceeding 14 drinks/week
Item
History of regular alcohol consumption exceeding 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
boolean
C0552479 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Recent use of prescription or non-prescription drugs, except for acetaminophen < 2 grams/day up until 48 hours of dosing
Item
Use of prescription or non-prescription drugs (other than acetaminophen at doses of <2 grams/day up until 48 hours of dosing) within seven days or 5 half-lives (whichever is longer) prior to Day 1 of Period 1 and throughout the study.
boolean
C0013227 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0000970 (UMLS CUI [1,4])
Use of vitamins and dietary/herbal supplements
Item
Use of vitamins and dietary/herbal supplements within 14 days prior to Day 1 of Period 1 and throughout the study.
boolean
C0242295 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0042890 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Use of tobacco or nicotine-containing products
Item
Use of tobacco or nicotine-containing products 60 days prior to dosing.
boolean
C0543414 (UMLS CUI [1])
C1514468 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0028040 (UMLS CUI [2,3])
Recent blood donation
Item
Donation of 500 mL of blood within 56 days prior to dosing.
boolean
C0005794 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Recent treatment with another experimental drug and another study participation
Item
Treatment with a new molecular entity (investigational drug) or any other trial during the previous 30 days or five half-lives, whichever is longer. A new molecular entity is defined as any compound not in Phase 3 (the washout is from last dose of study medication in the previous study until the first dose of study medication).
boolean
C0332185 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])