General health good Medical History | General health good Physical Examination | General health good ECG | General health good Vital signs | General health good Laboratory Procedures
Item
good general health as judged by the investigator, based on medical history, physical examination, electrocardiogram (ecg), vital signs and clinical laboratory
boolean
C1277245 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1277245 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1277245 (UMLS CUI [3,1])
C1623258 (UMLS CUI [3,2])
C1277245 (UMLS CUI [4,1])
C0518766 (UMLS CUI [4,2])
C1277245 (UMLS CUI [5,1])
C0022885 (UMLS CUI [5,2])
Body mass index
Item
body mass index (bmi) of 18.5-30.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Gender Sexually active Male sterilization Absent
Item
males who are sexually active and not surgically sterilised, who or whose partner(s):
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0024559 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Contraceptive methods Absent | Condoms | Spermicidal foam/jelly/cream/film/suppository | Contraceptive implant | Injectable contraception | Combined Oral Contraceptives | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Sexual Abstinence Absent | Sperm donation Absent | Sterilization Partner
Item
a. are not using adequate contraceptive methods (e.g. condom with spermicidal foam/gel/film/cream or contraceptives with a pearl index below 1%, such as implants, injectables, combined oral contraceptives, or hormonal intrauterine devices or diaphragm + spermicide) or b. do not refrain from sexual intercourse during the trial and until 30 days following the last dose of trial medication. in addition, subjects must not donate sperm for the duration of the trial and for 30 days following the last dose of trial medication or c. sterilization of either partner
boolean
C0700589 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0677582 (UMLS CUI [2])
C3843415 (UMLS CUI [3])
C1657106 (UMLS CUI [4])
C1262153 (UMLS CUI [5])
C0009906 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
C0042241 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
C0036899 (UMLS CUI [10,1])
C0332197 (UMLS CUI [10,2])
C0871414 (UMLS CUI [11,1])
C0332197 (UMLS CUI [11,2])
C0038288 (UMLS CUI [12,1])
C0682323 (UMLS CUI [12,2])
Life threatening illness | Disease Clinical Significance
Item
suffer from a life threatening disease or has a history of any clinically significant disease or disorder
boolean
C3846017 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Idiopathic acute pancreatitis | Pancreatitis, Chronic
Item
history of acute idiopathic or chronic pancreatitis
boolean
C0341461 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Calcitonin measurement
Item
calcitonin value equal to or above 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Laboratory test result abnormal | Haematology test abnormal | Abnormal biochemistry finding | Urine screening abnormal | Serum amylase raised | Serum lipase raised | Serum creatinine raised | Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Decreased platelet count | Increased number of platelets | White blood cell count abnormal | Serum sodium abnormal | Serum potassium abnormal
Item
any clinically significant abnormal laboratory test results (haematology, biochemistry and urinalysis), as judged by the investigator and any of the following laboratory safety results (based on screening results): amylase, lipase and creatinine, above upper normal range. aspartate aminotransferase (asat), alanine aminotransferase (alat) and gamma-glutamyl-transpeptidase (gamma-gt) above 1.5 times upper normal range (unr). thrombocytes below 0.75 times lower normal range (lnr) or above 1.25 times unr. leucocytes outside 3.0 to 11.0x10^9/l (normal range is 3.91 to 8.77x10^9/l. sodium outside the range 130.0 to 150.0 mmol/l (normal range is 136-145 mmol/l). potassium outside the range 3.0 to 5.5 mmol/l (normal range is 3.5 to 5.1 mmol/l)
boolean
C0438215 (UMLS CUI [1])
C1112712 (UMLS CUI [2])
C0586680 (UMLS CUI [3])
C0438142 (UMLS CUI [4])
C0476327 (UMLS CUI [5])
C3670924 (UMLS CUI [6])
C0700225 (UMLS CUI [7])
C0151904 (UMLS CUI [8])
C0151905 (UMLS CUI [9])
C0151662 (UMLS CUI [10])
C0392386 (UMLS CUI [11])
C0857460 (UMLS CUI [12])
C0580531 (UMLS CUI [13])
C0858176 (UMLS CUI [14])
C0858156 (UMLS CUI [15])
ECG abnormal
Item
any clinically significant abnormal ecg, as judged by the investigator
boolean
C0522055 (UMLS CUI [1])
Tobacco use
Item
subjects who are smokers
boolean
C0543414 (UMLS CUI [1])