Barrier Contraception Double | Sperm donation Absent
Item
must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
boolean
C0004764 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
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
Item
blood pressure (after the patient is supine for 5 minutes) between 100 and 140 mmhg systolic, inclusive, and between 50 and 90 mmhg diastolic
boolean
C1319895 (UMLS CUI [1])
C1319896 (UMLS CUI [2])
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])
Malignant Neoplasms | Exception Basal cell carcinoma
Item
history of any cancer, with the exception of basal cell carcinoma
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
Hematology finding abnormal | Clinical Chemistry Finding Abnormal | Urinalysis abnormal
Item
clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center
boolean
C0475182 (UMLS CUI [1])
C2347783 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0438142 (UMLS CUI [3])
Physical Examination Abnormal Finding | Abnormal vital signs | 12 lead ECG Abnormal
Item
clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ecg) at screening or at admission to the study center
boolean
C2826636 (UMLS CUI [1])
C0277804 (UMLS CUI [2])
C0430456 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
Signs Autonomic dysfunction | Standing systolic blood pressure Decrease | Standing diastolic blood pressure Decrease | Independent of Heart rate increased
Item
at screening, has signs of autonomic dysfunction as indicated by a decrease of > 20 mmhg in systolic blood pressure or a decrease of > 10 mmhg in diastolic blood pressure after standing for at least 2 minutes that is not associated with an increase of >15 beats per minute (bpm) in heart rate
boolean
C0311392 (UMLS CUI [1,1])
C1145628 (UMLS CUI [1,2])
C1303018 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C1303019 (UMLS CUI [3,1])
C0547047 (UMLS CUI [3,2])
C0332291 (UMLS CUI [4,1])
C0039231 (UMLS CUI [4,2])
Bradycardia 12 lead ECG | Heart rate 12 lead ECG
Item
bradycardia (heart rate <40 bpm) as determined by screening 12-lead ecg
boolean
C0428977 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0018810 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
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])
Substance Use Disorders | Substance Dependence
Item
history of, or a reason to believe a volunteer has a history of, drug or alcohol abuse and/or dependence within the past 5 years
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Drug-induced dystonia | Neuroleptic Malignant Syndrome
Item
known history of drug-induced dystonia or neuroleptic malignant syndrome
boolean
C0393595 (UMLS CUI [1])
C0027849 (UMLS CUI [2])
HIV antibody positive | Hepatitis B surface antigen positive | Hepatitis C antibody test positive
Item
positive test for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), or hepatitis c antibodies
boolean
C0920548 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1277805 (UMLS CUI [3])
Tobacco use | Substance Containing Nicotine
Item
history of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or volunteer's verbal report
boolean
C0543414 (UMLS CUI [1])
C0439861 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0028040 (UMLS CUI [2,3])