Part Number
Item
part 1:
boolean
C0449719 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Metformin
Item
has a historical diagnosis of t2dm disease, on diet and exercise or on metformin
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
Body Weight | Body mass index
Item
weighs at least 55 kg and has a body mass index (bmi) from 25.0 to 30.0 kg/m^2, inclusive at screening
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Systolic Pressure | Diastolic blood pressure
Item
has a systolic blood pressure >90 and ≤150 mm hg and a diastolic blood pressure of >60 and ≤90 mm hg at screening and at check-in (day -2)
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
has a calculated creatinine clearance >60 ml/min at screening and check-in (day -2)
boolean
C2711451 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hemoglobin a1c (hba1c) level between 7.0% and 10.0%, inclusive
boolean
C0474680 (UMLS CUI [1])
Part Number
Item
part 2:
boolean
C0449719 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Healthy Volunteers Japanese
Item
health participants of japanese origin
boolean
C1708335 (UMLS CUI [1,1])
C1556094 (UMLS CUI [1,2])
Part Number
Item
part 1 and part 2:
boolean
C0449719 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Investigational New Drugs
Item
has received any investigational compound within 30 days prior to the first dose of study medication
boolean
C0013230 (UMLS CUI [1])
Gastrointestinal Diseases | Major Depressive Disorder | At risk for suicide | Pregnancy | Breast Feeding | Pregnancy, Planned | Ovum Donation intended
Item
history of significant gastrointestinal (gi) disorders part 1, has diagnosis of major depression and risk of suicide, part 1, is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period
boolean
C0017178 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
C0563664 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0006147 (UMLS CUI [5])
C0032992 (UMLS CUI [6])
C0242812 (UMLS CUI [7,1])
C1283828 (UMLS CUI [7,2])
Sperm donation intended
Item
intends to donate sperm during the course of this study or for 12 weeks thereafter
boolean
C0871414 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Basal cell carcinoma Remission Duration
Item
has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years prior to day 1
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0687702 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Infection
Item
has a positive test result for hepatitis b surface antigen (hbsag), antibody to hepatitis c virus (anti-hcv), at screening or a known history of human immunodeficiency virus infection
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Nicotine product | Cigarette | Pipe | Cigars | Oral Tobacco | Nicotine Patch | Nicotine Gum | Urine cotinine test positive
Item
has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to check-in (day -2). cotinine test is positive at screening or check-in (day -2)
boolean
C0028040 (UMLS CUI [1])
C0677453 (UMLS CUI [2])
C0678447 (UMLS CUI [3])
C0678446 (UMLS CUI [4])
C0008038 (UMLS CUI [5])
C0358855 (UMLS CUI [6])
C0599654 (UMLS CUI [7])
C1699505 (UMLS CUI [8])
Diabetes Mellitus, Insulin-Dependent | Loss of hypoglycemic warning | Diabetic Ketoacidosis | Hyperosmolar Coma
Item
history of t1dm, hypoglycemia unawareness, diabetic ketoacidosis, or hyperosmolar coma
boolean
C0011854 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
C0011880 (UMLS CUI [3])
C0020457 (UMLS CUI [4])
Hypoglycemic Agents | Exception Metformin
Item
has received any antihyperglycemic medication with the exception of metformin within the previous 12 weeks of check-in (day -2)
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])