Healthy | Age | Abnormality Clinical Absent | Medical History | Physical Examination | Blood pressure determination | Pulse rate finding | 12 lead ECG | Laboratory Procedures
Item
healthy male and/or female 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
C3898900 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0262926 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0005824 (UMLS CUI [6])
C0577836 (UMLS CUI [7])
C0430456 (UMLS CUI [8])
C0022885 (UMLS CUI [9])
Pulmonary function tests | Ophthalmic examination
Item
in addition, subjects must have normal pulmonary function tests and normal ocular examination.
boolean
C0024119 (UMLS CUI [1])
C0200149 (UMLS CUI [2])
Body mass index | Body Weight
Item
body mass index (bmi) of 25.5 - 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Gender Childbearing Potential Absent
Item
women must be of non-childbearing potential.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Metformin | Requirement Washout Sulfonylurea | Requirement Washout Dipeptidyl Peptidase 4 Inhibitors
Item
subjects with type 2 diabetes: hba1c ≥7.0% and ≤10.0% if on metformin only, and ≥6.5% and ≤9.0% if patient requires to be washed-off an su or dpp-4i.
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C1710661 (UMLS CUI [4,2])
C0038766 (UMLS CUI [4,3])
C1514873 (UMLS CUI [5,1])
C1710661 (UMLS CUI [5,2])
C2917254 (UMLS CUI [5,3])
Diabetes Mellitus, Non-Insulin-Dependent | CYP3A4 Substrate Absent | CYP3A5 Substrate Absent | CYP2D6 Substrate Absent
Item
for subjects with type 2 diabetes, due to possible effects on disposition, cyp p450 3a4/5 and 2d6 substrates should not be co-administered with study medications.
boolean
C0011860 (UMLS CUI [1])
C3714798 (UMLS CUI [2,1])
C3891814 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3714750 (UMLS CUI [3,1])
C3891814 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0057223 (UMLS CUI [4,1])
C3891814 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Hematological Disease | Kidney Disease | Endocrine System Disease | Gastrointestinal Disease | Cardiovascular Disease | Liver disease | Mental disorders | Nervous system disorder | Hypersensitivity | Drug Allergy | Exception Hay fever Asymptomatic Untreated
Item
evidence or history of clinically significant hematological, renal, endocrine, 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])
C0017178 (UMLS CUI [4])
C0007222 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0020517 (UMLS CUI [9])
C0013182 (UMLS CUI [10])
C1705847 (UMLS CUI [11,1])
C0018621 (UMLS CUI [11,2])
C0231221 (UMLS CUI [11,3])
C0332155 (UMLS CUI [11,4])
Chronic lung disease | Lung disease
Item
evidence or history of any chronic ongoing or current pulmonary disease.
boolean
C0746102 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
Smoking History | Smoking cigarettes: ____ pack-years history | Non-smoked tobacco | Nicotine product | Urine cotinine test positive
Item
history of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products within 3 months of screening, or positive cotinine test at screening or day -3.
boolean
C1519384 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
C4296981 (UMLS CUI [3])
C0028040 (UMLS CUI [4])
C1699505 (UMLS CUI [5])
Disorder of eye | Eye Infection | Glaucoma | Hay fever | Dryness of eye Symptoms | Retinal Disease | Disorder of the optic nerve
Item
active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
boolean
C0015397 (UMLS CUI [1])
C0015403 (UMLS CUI [2])
C0017601 (UMLS CUI [3])
C0018621 (UMLS CUI [4])
C0314719 (UMLS CUI [5,1])
C1457887 (UMLS CUI [5,2])
C0035309 (UMLS CUI [6])
C0029132 (UMLS CUI [7])