Healthy Volunteers | Childbearing Potential Absent | Age | Abnormality Absent | Medical History | Physical Examination | Blood pressure determination | Pulse Rate | 12 lead ECG | Laboratory Procedures
Item
healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests).
boolean
C1708335 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C1704258 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0262926 (UMLS CUI [5])
C0031809 (UMLS CUI [6])
C0005824 (UMLS CUI [7])
C0232117 (UMLS CUI [8])
C0430456 (UMLS CUI [9])
C0022885 (UMLS CUI [10])
Body mass index | Body Weight
Item
body mass index (bmi) of 17.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Hematological Disease | Kidney Disease | Endocrine System Disease | Lung disease | Gastrointestinal Disease | Cardiovascular Disease | Liver disease | Mental disorder | Nervous system disorder | Disease allergic | Drug Allergy | Exception Hypersensitivity Untreated | Exception Hypersensitivity Asymptomatic | Exception Seasonal allergies
Item
evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
boolean
C0018939 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0012634 (UMLS CUI [10,1])
C0700624 (UMLS CUI [10,2])
C0013182 (UMLS CUI [11])
C1705847 (UMLS CUI [12,1])
C0020517 (UMLS CUI [12,2])
C0332155 (UMLS CUI [12,3])
C1705847 (UMLS CUI [13,1])
C0020517 (UMLS CUI [13,2])
C0231221 (UMLS CUI [13,3])
C1705847 (UMLS CUI [14,1])
C0018621 (UMLS CUI [14,2])
Condition Affecting Drug absorption | Gastrectomy
Item
any condition possibly affecting drug absorption (eg, gastrectomy).
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0017118 (UMLS CUI [2])
Alcohol consumption Regular Drinks per week | Gender | Wine oz/week | Beer oz/week | Hard liquor intake oz/week
Item
history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening.
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0001967 (UMLS CUI [1,3])
C0332174 (UMLS CUI [1,4])
C0079399 (UMLS CUI [2])
C0043188 (UMLS CUI [3,1])
C0556977 (UMLS CUI [3,2])
C0004922 (UMLS CUI [4,1])
C0556977 (UMLS CUI [4,2])
C0559433 (UMLS CUI [5,1])
C0556977 (UMLS CUI [5,2])
Tobacco use Number of cigarettes per day | Nicotine product Equivalent Number of cigarettes per day
Item
use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C0028040 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C3694146 (UMLS CUI [2,3])
Hypoglycemia | Glucose measurement, fasting
Item
self-reported history of hypoglycemia, or fasting laboratory glucose value </=80 mg/dl at screening or day 0 of period 1, confirmed by a single repeat if deemed necessary.
boolean
C0020615 (UMLS CUI [1])
C0202045 (UMLS CUI [2])