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 the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Body Weight
Item
body weight of equal to or above 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])
Japanese | Parent Both Japanese
Item
for japanese subjects only: both parents japanese
boolean
C1556094 (UMLS CUI [1])
C0030551 (UMLS CUI [2,1])
C1706086 (UMLS CUI [2,2])
C1556094 (UMLS CUI [2,3])
Caucasians | Parent Both Caucasian
Item
for caucasian subjects only: both parents caucasian
boolean
C0043157 (UMLS CUI [1])
C0030551 (UMLS CUI [2,1])
C1706086 (UMLS CUI [2,2])
C0043157 (UMLS CUI [2,3])
Disease Clinical Significance | Systemic disease | Organ Disease | Heart Diseases | Lung diseases | Gastrointestinal Diseases | Liver diseases | Nervous system disorder | Kidney Diseases | Disorder of the genitourinary system | Endocrine System Diseases | Dermatologic disorders | Hematological Disease
Item
any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiological, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2])
C0178784 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0022658 (UMLS CUI [9])
C0080276 (UMLS CUI [10])
C0014130 (UMLS CUI [11])
C0037274 (UMLS CUI [12])
C0018939 (UMLS CUI [13])
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 or multiple endocrine neoplasia syndrome 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])
Calcitonin measurement
Item
calcitonin above or equal to 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Alcohol abuse | Breath alcohol test positive | Alcohol consumption units/week | Beer units/week | Lager units/week | Wine units/week | Sake units/week | Spirits units/week
Item
history of alcohol abuse within 1 year from screening, or a positive result in the alcohol breath test, or consumption of more than 21 units of alcohol weekly: 1 unit of alcohol equals approximately 250 ml of beer or lager, or approximately120 ml (one glass) of wine or japanese sake, or approximately 20 ml of spirits
boolean
C0085762 (UMLS CUI [1])
C1112499 (UMLS CUI [2])
C0001948 (UMLS CUI [3,1])
C0560579 (UMLS CUI [3,2])
C0004922 (UMLS CUI [4,1])
C0560579 (UMLS CUI [4,2])
C0452245 (UMLS CUI [5,1])
C0560579 (UMLS CUI [5,2])
C0043188 (UMLS CUI [6,1])
C0560579 (UMLS CUI [6,2])
C0678393 (UMLS CUI [7,1])
C0560579 (UMLS CUI [7,2])
C0301611 (UMLS CUI [8,1])
C0560579 (UMLS CUI [8,2])
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 | Dietary Supplements 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 (randomisation), non-prescription drugs within 1 week prior to visit 2 (randomisation). the use of vitamins, minerals and nutritional supplements, 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])
C0242295 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0000970 (UMLS CUI [6,1])
C0521114 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C0004057 (UMLS CUI [7,1])
C0521114 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])