Contraceptive methods | Sperm donation Absent
Item
must agree to use an efficient method of birth control as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
boolean
C0700589 (UMLS CUI [1])
C0871414 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Body mass index | Body Weight
Item
body mass index (weight [kg]/height [m2]) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Lying systolic blood pressure | Lying diastolic blood pressure | Pulse Rate
Item
blood pressure (after the volunteer is supine for 5 minutes) between 100 and 140 mmhg systolic, inclusive, and between 50 and 90 mmhg diastolic. pulse rate measured over 60 seconds should be between 40 and 100 beats per minute (bpm)
boolean
C1319895 (UMLS CUI [1])
C1319896 (UMLS CUI [2])
C0232117 (UMLS CUI [3])
Non-smoker
Item
non-smoker
boolean
C0337672 (UMLS CUI [1])
Illness Significant | Cardiac Arrhythmia | Heart Diseases | Hematological Disease | Blood Coagulation Disorders | Bleeding tendency | Lipids abnormal | Lung diseases | Bronchial Spasm Associated with Respiration Disorders | Diabetes Mellitus | Renal Insufficiency | Hepatic Insufficiency | Thyroid Diseases | Nervous system disorder | Mental disorders | Communicable Disease
Item
history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the volunteer
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0005779 (UMLS CUI [5])
C1458140 (UMLS CUI [6])
C0549634 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0006266 (UMLS CUI [9,1])
C0332281 (UMLS CUI [9,2])
C0035204 (UMLS CUI [9,3])
C0011849 (UMLS CUI [10])
C1565489 (UMLS CUI [11])
C1306571 (UMLS CUI [12])
C0040128 (UMLS CUI [13])
C0027765 (UMLS CUI [14])
C0004936 (UMLS CUI [15])
C0009450 (UMLS CUI [16])
At risk Torsades de Pointes | Risk of sudden death | Prolonged QT interval Drug-induced | Bradycardia | Heart rate ECG | ECG abnormal | QTcF Prolongation ECG Quantity
Item
history or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the qtc interval, including: bradycardia (heart rate < 40 bpm on the ecg), clinically significant abnormality on the ecg, demonstration of repeated prolonged qtcf > 450 ms (qtc interval corrected for heart rate using fridericia's formula), as measured on more than one ecg (either during screening, or from prior medical record)
boolean
C1444641 (UMLS CUI [1,1])
C0040479 (UMLS CUI [1,2])
C4014370 (UMLS CUI [2])
C0151878 (UMLS CUI [3,1])
C0458082 (UMLS CUI [3,2])
C0428977 (UMLS CUI [4])
C0018810 (UMLS CUI [5,1])
C0013798 (UMLS CUI [5,2])
C0522055 (UMLS CUI [6])
C3828431 (UMLS CUI [7,1])
C0013798 (UMLS CUI [7,2])
C1265611 (UMLS CUI [7,3])
Heart Diseases | Sick Sinus Syndrome | Complete atrioventricular block | Congestive heart failure | Ventricular tachycardia, polymorphic
Item
the following cardiac conditions: sick sinus syndrome, complete av block, congestive heart failure, polymorphic ventricular tachycardia
boolean
C0018799 (UMLS CUI [1])
C0037052 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0344432 (UMLS CUI [5])
Hypocalcemia | Hypokalemia | Hypomagnesemia
Item
clinically relevant hypocalcemia, hypokalemia or hypomagnesemia
boolean
C0020598 (UMLS CUI [1])
C0020621 (UMLS CUI [2])
C0151723 (UMLS CUI [3])
Prolonged QT interval Congenital | Romano-Ward Syndrome | Jervell-Lange Nielsen Syndrome
Item
presence of congenital prolongation of the qt interval (romano-ward syndrome, jervell and lange-nielsen syndrome)
boolean
C0151878 (UMLS CUI [1,1])
C1744681 (UMLS CUI [1,2])
C4551647 (UMLS CUI [2])
C0022387 (UMLS CUI [3])
Malignant Neoplasms | Exception Basal cell carcinoma | Hematology finding abnormal | Clinical Chemistry Finding Abnormal | Urinalysis abnormal
Item
history of any cancer, with the exception of basal cell carcinoma: clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center, in the opinion of the investigator
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0475182 (UMLS CUI [3])
C2347783 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
C0438142 (UMLS CUI [5])
Physical Examination Abnormal Finding
Item
clinically significant abnormality on physical examination, in the opinion of the investigator
boolean
C2826636 (UMLS CUI [1])
Signs Orthostatic Hypotension | Standing systolic blood pressure Decrease | Standing diastolic blood pressure Decrease | Pulse Rate Increase | Comparison Measurement Supine Position
Item
at screening, has signs of orthostatic hypotension defined as a decrease in systolic ( > 20 mmhg) or diastolic (> 10 mmhg) blood pressure after standing for at least 2 minutes, that is associated with an increase in pulse rate of >15 bpm compared with supine measurements
boolean
C0311392 (UMLS CUI [1,1])
C0020651 (UMLS CUI [1,2])
C1303018 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C1303019 (UMLS CUI [3,1])
C0547047 (UMLS CUI [3,2])
C0232117 (UMLS CUI [4,1])
C0442805 (UMLS CUI [4,2])
C1707455 (UMLS CUI [5,1])
C0242485 (UMLS CUI [5,2])
C0038846 (UMLS CUI [5,3])
Prescription Drugs | Drugs, Non-Prescription | Vitamins | Herbal Supplements | Exception Acetaminophen | Exception Ibuprofen
Item
use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen) or ibuprofen, within 14 days before the first dose of the study drug is scheduled
boolean
C0304227 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0000970 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0020740 (UMLS CUI [6,2])