Caucasian | Gender | Age
Item
caucasian male aged 30 to 65 at screening.
boolean
C0043157 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Body Weight | Body mass index
Item
body weight of ≥60 kg, and a bmi ranging from 18.0 to 32.0 kg/m2 at screening and day-1.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
ECG normal | Heart rate
Item
normal or not clinically significant ecg as defined by a hr between 50 and 100 bpm inclusive at screening, day -1 and pre-dose.
boolean
C0522054 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
Vital signs | Body temperature measurement | Systolic Pressure | Diastolic blood pressure
Item
vital signs within the following ranges at screening and day -1,body temperature: 35.0 to 37.5 °c,sbp: 90 to 140 mmhg,dbp: 50 to 90 mmhg.
boolean
C0518766 (UMLS CUI [1])
C0886414 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Bowel movements Regular
Item
regular daily bowel movements.
boolean
C0011135 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Exposure to radiation | Exception Background Radiation | Diagnostic radiologic examination
Item
radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 msv in the last 12 months or 10 msv in the last 5 years. no occupationally exposed worker, as defined in the ionising radiation regulations 1999, shall participate in the study.
boolean
C0015333 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004607 (UMLS CUI [2,2])
C0043299 (UMLS CUI [3])
Tuberculosis | Herpes Labialis Recurrent | Pharyngitis Recurrent | Urinary tract infection Recurrent | Diarrhea Recurrent | Dysentery Recurrent | Lower respiratory tract infection Recurrent | Mycoses Recurrent
Item
previous medical history of tuberculosis, or in the opinion of the investigator, a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections or fungal infections.
boolean
C0041296 (UMLS CUI [1])
C0019345 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0031350 (UMLS CUI [3,1])
C2945760 (UMLS CUI [3,2])
C0042029 (UMLS CUI [4,1])
C2945760 (UMLS CUI [4,2])
C0011991 (UMLS CUI [5,1])
C2945760 (UMLS CUI [5,2])
C0013369 (UMLS CUI [6,1])
C2945760 (UMLS CUI [6,2])
C0149725 (UMLS CUI [7,1])
C2945760 (UMLS CUI [7,2])
C0026946 (UMLS CUI [8,1])
C2945760 (UMLS CUI [8,2])
Operative Surgical Procedures Changing Drug absorption | Operative Surgical Procedures Changing Drug distribution | Operative Surgical Procedures Changing Drug metabolism | Operative Surgical Procedures Changing Drug elimination | Medical condition Changing Drug absorption | Medical condition Changing Drug distribution | Medical condition Changing Drug metabolism | Medical condition Changing Drug elimination | Operative Surgical Procedures Study Subject Participation Status At risk | Medical condition Study Subject Participation Status At risk
Item
any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case or participation in the study. the investigator should be guided by evidence of any of the following:
boolean
C0543467 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0392747 (UMLS CUI [5,2])
C0678745 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0392747 (UMLS CUI [6,2])
C0699903 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0392747 (UMLS CUI [7,2])
C0683140 (UMLS CUI [7,3])
C3843040 (UMLS CUI [8,1])
C0392747 (UMLS CUI [8,2])
C0683141 (UMLS CUI [8,3])
C0543467 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C3843040 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
Inflammatory Bowel Disease | Gastritis | Ulcer | Gastrointestinal Hemorrhage | Rectal hemorrhage
Item
history of inflammatory bowel syndrome,gastritis, ulcers, gastrointestinal or rectal bleeding;
boolean
C0021390 (UMLS CUI [1])
C0017152 (UMLS CUI [2])
C0041582 (UMLS CUI [3])
C0017181 (UMLS CUI [4])
C0267596 (UMLS CUI [5])
Gastrointestinal Surgical Procedure Major | Gastrectomy | Gastroenterostomy | Bowel resection
Item
history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
boolean
C0524722 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0017118 (UMLS CUI [2])
C0017164 (UMLS CUI [3])
C0741614 (UMLS CUI [4])