Gender | Healthy Volunteers | Japanese | Caucasians
Item
healthy male japanese and caucasian subjects
boolean
C0079399 (UMLS CUI [1])
C1708335 (UMLS CUI [2])
C1556094 (UMLS CUI [3])
C0043157 (UMLS CUI [4])
Age | Informed Consent
Item
age between 20 and 55 years (both inclusive) at time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Body Weight
Item
body weight of above or equal to 54.0 kg
boolean
C0005910 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 20.0 and 25.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin a1c (hba1c) below or equal to 6.0%
boolean
C0474680 (UMLS CUI [1])
Diabetes Mellitus | Malignant Neoplasms | Heart Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Dermatologic disorders | Sexually Transmitted Diseases | Hematological Disease | Nervous system disorder | Mental disorders | Disease At risk Patient safety | Disease Protocol Compliance At risk
Item
presence or history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gi (gastrointestinal), endocrine, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders, as judged by the investigator. any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
boolean
C0011849 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0017178 (UMLS CUI [8])
C0014130 (UMLS CUI [9])
C0037274 (UMLS CUI [10])
C0036916 (UMLS CUI [11])
C0018939 (UMLS CUI [12])
C0027765 (UMLS CUI [13])
C0004936 (UMLS CUI [14])
C0012634 (UMLS CUI [15,1])
C1444641 (UMLS CUI [15,2])
C1113679 (UMLS CUI [15,3])
C0012634 (UMLS CUI [16,1])
C0525058 (UMLS CUI [16,2])
C1444641 (UMLS CUI [16,3])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Tobacco use Number of cigarettes per day | Nicotine product Alternative | Refrain from Smoking Unwilling
Item
smoking of more than 5 cigarettes (including nicotine substitute products), or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C0028040 (UMLS CUI [2,1])
C1523987 (UMLS CUI [2,2])
C4086797 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Prescription Drugs | Drugs, Non-Prescription | Vitamins allowed | Minerals allowed | Acetaminophen occasional allowed | Aspirin occasional allowed
Item
use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to visit 2 (day 1), non-prescription drugs within 1 week prior to visit 2 (day 1). the use of vitamins and minerals, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted
boolean
C0304227 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042890 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0026162 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0000970 (UMLS CUI [5,1])
C0521114 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
C0004057 (UMLS CUI [6,1])
C0521114 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
Blood draw Excess Amount | Blood Donation Excess Amount | Plasma Donation Excess Amount
Item
any blood drawn in excess of 25 ml in the past month, or donation of blood or plasma in excess of 400 ml within the 3 months preceding screening
boolean
C0005834 (UMLS CUI [1,1])
C1979886 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0005794 (UMLS CUI [2,1])
C1979886 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0032105 (UMLS CUI [3,1])
C0680854 (UMLS CUI [3,2])
C1979886 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Gastrointestinal Surgical Procedure | Invasive procedure Involving Esophagus | Invasive procedure Involving Stomach | Invasive procedure Involving Duodenum | Invasive procedure Involving Gallbladder | Cholecystectomy | Pancreatectomy | Intestinal resection | Exception Operative Surgical Procedures Uncomplicated | Exception Diagnostic procedure Uncomplicated | Exception Appendectomy | Exception Hernia Surgery | Exception Resection of polyp | Exception Biopsy | Exception Colonoscopy | Exception Endoscopy of stomach
Item
previous gi surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder (e.g., cholecystectomy), pancreas or intestinal resections. exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic and gastric endoscopy
boolean
C0524722 (UMLS CUI [1])
C4048276 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0014876 (UMLS CUI [2,3])
C4048276 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0038351 (UMLS CUI [3,3])
C4048276 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0013303 (UMLS CUI [4,3])
C4048276 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0016976 (UMLS CUI [5,3])
C0008320 (UMLS CUI [6])
C0030279 (UMLS CUI [7])
C1096244 (UMLS CUI [8])
C1705847 (UMLS CUI [9,1])
C0543467 (UMLS CUI [9,2])
C0443334 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0430022 (UMLS CUI [10,2])
C0443334 (UMLS CUI [10,3])
C1705847 (UMLS CUI [11,1])
C0003611 (UMLS CUI [11,2])
C1705847 (UMLS CUI [12,1])
C3826215 (UMLS CUI [12,2])
C1705847 (UMLS CUI [13,1])
C0521210 (UMLS CUI [13,2])
C1705847 (UMLS CUI [14,1])
C0005558 (UMLS CUI [14,2])
C1705847 (UMLS CUI [15,1])
C0009378 (UMLS CUI [15,2])
C1705847 (UMLS CUI [16,1])
C0017195 (UMLS CUI [16,2])