Caucasians | Gender | Healthy Volunteers | Age
Item
caucasian, male healthy subjects of 18 to 45 years of age (inclusive).
boolean
C0043157 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C1708335 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
Body Weight | Body mass index
Item
body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Informed Consent
Item
subjects will sign and date an informed consent form before any study-specific screening procedure is performed.
boolean
C0021430 (UMLS CUI [1])
Healthy Medical History | Healthy Physical Examination | Healthy Laboratory test result | Healthy Vital signs measurements | Healthy 12 lead ECG
Item
healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ecg readings.
boolean
C3898900 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C3898900 (UMLS CUI [3,1])
C0587081 (UMLS CUI [3,2])
C3898900 (UMLS CUI [4,1])
C2963216 (UMLS CUI [4,2])
C3898900 (UMLS CUI [5,1])
C0430456 (UMLS CUI [5,2])
Non-smoker | Tobacco use Number of cigarettes per day | Ability Refrain from Smoking
Item
non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. must be able to abstain from smoking during the inpatient stay.
boolean
C0337672 (UMLS CUI [1])
C0543414 (UMLS CUI [2,1])
C3694146 (UMLS CUI [2,2])
C0085732 (UMLS CUI [3,1])
C4086797 (UMLS CUI [3,2])
Probability High Compliance behavior | Probability High Completion of clinical trial
Item
have a high probability for compliance with and completion of the study.
boolean
C0033204 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0033204 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Gastrointestinal Diseases | Endocrine System Diseases | Immune System Diseases | Dermatologic disorders | Hematological Disease | Nervous system disorder | Mental disorders | Drug Allergy
Item
any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy.
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0021053 (UMLS CUI [7])
C0037274 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0027765 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0013182 (UMLS CUI [12])
Acute illness
Item
acute disease state within 7 days before study day 1.
boolean
C4061114 (UMLS CUI [1])
Drug abuse
Item
history of drug abuse within 1 year before study day 1.
boolean
C0013146 (UMLS CUI [1])
Alcoholic Intoxication, Chronic | Alcohol consumption Gram per day
Item
history of alcoholism within 1 year before day 1. consumption of more than 50 g of ethanol per day.
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
Serology positive HIV Antibodies | Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis C Antibodies
Item
positive serologic findings for human immunodeficiency virus antibodies, hepatitis b surface antigen, and/or hepatitis c virus antibodies.
boolean
C0242089 (UMLS CUI [1,1])
C0019683 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019168 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0166049 (UMLS CUI [3,2])
Urine drug screen positive | Amphetamines | Barbiturates | Benzodiazepines | Cannabinoids | Cocaine | Methadone | Opiates | Ecstasy
Item
positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, mdma)
boolean
C0743300 (UMLS CUI [1])
C0002667 (UMLS CUI [2])
C0004745 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
C0006864 (UMLS CUI [5])
C0009170 (UMLS CUI [6])
C0025605 (UMLS CUI [7])
C0376196 (UMLS CUI [8])
C0115471 (UMLS CUI [9])
Drug Allergy
Item
history of any clinically important drug allergy.
boolean
C0013182 (UMLS CUI [1])
Therapeutic procedure Illicit | Investigational New Drugs Recent | Prescription Drugs Recent
Item
prohibited treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration.
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0304227 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
Pharmaceutical Preparations Containing Caffeine | Consumption Excessive cups per day | GRAPEFRUIT EXTRACT | Pharmaceutical Preparations Containing GRAPEFRUIT EXTRACT | Alcoholic Beverages
Item
consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
boolean
C0013227 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0006644 (UMLS CUI [1,3])
C0009830 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
C0560654 (UMLS CUI [2,3])
C0440280 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0332256 (UMLS CUI [4,2])
C0440280 (UMLS CUI [4,3])
C0001967 (UMLS CUI [5])
Drugs, Non-Prescription | Herbal Supplements | Exception Acetaminophen | Exception Aspirin | Exception Vitamins
Item
use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration.
boolean
C0013231 (UMLS CUI [1])
C1504473 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0004057 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0042890 (UMLS CUI [5,2])
Blood Donation Amount Timespan
Item
donation of blood (i.e. 450 ml) within 90 days before study day 1.
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])