Informed Consent
Item
1. a signed and dated informed consent form before any study-specific screening procedure is performed.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. aged between 18 and 45 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
Healthy Medical History | Healthy Physical Examination | Healthy Laboratory Results | Healthy Vital signs | Healthy 12 lead ECG
Item
3. healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ecg).
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])
C1254595 (UMLS CUI [3,2])
C3898900 (UMLS CUI [4,1])
C0150404 (UMLS CUI [4,2])
C3898900 (UMLS CUI [5,1])
C0430456 (UMLS CUI [5,2])
Non-smoker | Tobacco use Number of cigarettes per day | Avoidance Tobacco use During Inpatient stay
Item
4. nonsmoker or smoker of fewer than 10 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])
C0870186 (UMLS CUI [3,1])
C0543414 (UMLS CUI [3,2])
C0347984 (UMLS CUI [3,3])
C0420512 (UMLS CUI [3,4])
Cardiovascular Diseases | Hypertensive disease | Liver diseases | Kidney Diseases | Respiration Disorders | Childhood asthma | Gastrointestinal Diseases | Endocrine System Diseases | Diabetes Mellitus | Dyslipidemia | Immune System Diseases | Dermatologic disorders | Hematological Disease | Nervous system disorder | Mental disorders
Item
1. any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
boolean
C0007222 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0264408 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0011849 (UMLS CUI [9])
C0242339 (UMLS CUI [10])
C0021053 (UMLS CUI [11])
C0037274 (UMLS CUI [12])
C0018939 (UMLS CUI [13])
C0027765 (UMLS CUI [14])
C0004936 (UMLS CUI [15])
Nausea | Vomiting | Fever | Diarrhea
Item
2. acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
boolean
C0027497 (UMLS CUI [1])
C0042963 (UMLS CUI [2])
C0015967 (UMLS CUI [3])
C0011991 (UMLS CUI [4])
Drug abuse
Item
3. history of drug abuse within 1 year before study day 1.
boolean
C0013146 (UMLS CUI [1])
Alcoholic Intoxication, Chronic | Consumption Ethanol g/day | Consumption Wine g/day | Consumption Aperitif wine cl per day | Consumption Whisky g/day | Consumption Beer g/day
Item
4. history of alcoholism within 1 year before day 1. consumption of more than 50 g of ethanol per day (12.5 cl glass of 10° [10%] wine = 12 g; 4 cl of aperitif, 42° [42%] whiskey = 17 g; 25 cl glass of 3° [3%] beer = 7.5 g; 25 cl glass of 6° [6%] beer = 15 g
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0001962 (UMLS CUI [2,2])
C0439417 (UMLS CUI [2,3])
C0001948 (UMLS CUI [3,1])
C0043188 (UMLS CUI [3,2])
C0439417 (UMLS CUI [3,3])
C0001948 (UMLS CUI [4,1])
C0678400 (UMLS CUI [4,2])
C0475212 (UMLS CUI [4,3])
C0439505 (UMLS CUI [4,4])
C0001948 (UMLS CUI [5,1])
C0475610 (UMLS CUI [5,2])
C0439417 (UMLS CUI [5,3])
C0001948 (UMLS CUI [6,1])
C0004922 (UMLS CUI [6,2])
C0439417 (UMLS CUI [6,3])
BIA 9-1067
Item
5. have previously received bia 9-1067.
boolean
C2933913 (UMLS CUI [1])
HIV antibody positive | Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis C Antibodies
Item
6. positive serologic findings for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), and/or hepatitis c virus (hcv) antibodies.
boolean
C0920548 (UMLS CUI [1])
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 - drug
Item
7. positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, mdma [3,4-methylenedioxy-methamphetamine; ecstasy]).
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
8. history of any clinically important drug allergy.
boolean
C0013182 (UMLS CUI [1])
Investigational New Drugs Recently | Pharmaceutical Preparations Recently
Item
9. prohibited treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (imp) administration.
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Consumption of Caffeine containing substance Excessive | Coffee | Tea | Hot chocolate drink | Soda | Consumption of GRAPEFRUIT Excessive | Consumption of product containing Grapefruit | Consumption of Alcoholic Beverages Excessive
Item
10. consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 before study day 1.
boolean
C0009830 (UMLS CUI [1,1])
C0565794 (UMLS CUI [1,2])
C0442802 (UMLS CUI [1,3])
C0009237 (UMLS CUI [2])
C0039400 (UMLS CUI [3])
C0452243 (UMLS CUI [4])
C0683086 (UMLS CUI [5])
C0009830 (UMLS CUI [6,1])
C0452456 (UMLS CUI [6,2])
C0442802 (UMLS CUI [6,3])
C0009830 (UMLS CUI [7,1])
C0681562 (UMLS CUI [7,2])
C0332256 (UMLS CUI [7,3])
C0995150 (UMLS CUI [7,4])
C0009830 (UMLS CUI [8,1])
C0001967 (UMLS CUI [8,2])
C0442802 (UMLS CUI [8,3])
Drugs, Non-Prescription | Herbal Supplements | Exception Acetaminophen occasional | Exception Aspirin occasional | Exception Vitamins occasional
Item
11. 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 imp administration.
boolean
C0013231 (UMLS CUI [1])
C1504473 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
C0521114 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0004057 (UMLS CUI [4,2])
C0521114 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0042890 (UMLS CUI [5,2])
C0521114 (UMLS CUI [5,3])
Blood Donation Amount
Item
12. donation of blood (ie 450 ml) within 90 days before study day 1.
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])