Healthy Volunteers | Physical Examination | Medical History | Laboratory Procedures | Electrocardiogram Triplicate | Vital signs | Body mass index | Non-smoker
Item
healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, triplicate electrocardiogram and vital signs, performed at screening, have a body mass index (bmi, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included and be non-smoking for at least 3 months prior to selection
boolean
C1708335 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
C0013798 (UMLS CUI [5,1])
C0205174 (UMLS CUI [5,2])
C0518766 (UMLS CUI [6])
C1305855 (UMLS CUI [7])
C0337672 (UMLS CUI [8])
Chronic Hepatitis C Genotype | Absence Comorbidity Relevance Clinical | Body mass index
Item
chronic hepatitis-c infected patients should have documented chronic genotype 1a or 1b hcv infection, otherwise no clinically relevant currently active disease and a bmi of 18.0 to 35.0 kg/m2, extremes included
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
C0205210 (UMLS CUI [2,4])
C1305855 (UMLS CUI [3])
Postmenopausal state | Female Sterilization
Item
women must be postmenopausal for at least 2 years, and/or be surgically sterile.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
Drug Allergy | Allergy to sulfonamides | Allergy to penicillin | Hypersensitivity Investigational New Drugs
Item
all participants with a drug allergy such as, but not limited to, sulfonamides and penicillins, or with a drug allergy as witnessed in previous trials with experimental drugs
boolean
C0013182 (UMLS CUI [1])
C0038757 (UMLS CUI [2])
C0030824 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
Pharmaceutical Preparations Additional | Drugs, Non-Prescription | Herbal medicine (product) | Dietary Supplements | Exception Acetaminophen | Exception Ibuprofen | Exception Hormone replacement therapy | Exception Products Chronic Hepatitis C | CYP3A4 Inhibitors Excluded | CYP3A4 Inducers Excluded | Methadone Stable Excluded
Item
use of concomitant medication, including over-the-counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen or hormone replacement therapy or for chronic hepatitis-c infected patients products that are not cyp3a4 inhibitors or inducers and stable use of methadone, in a period of 14 days before the first trial medication administration
boolean
C0013227 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2])
C2240391 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0000970 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0020740 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0282402 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C1254351 (UMLS CUI [8,2])
C0524910 (UMLS CUI [8,3])
C3850053 (UMLS CUI [9,1])
C0332196 (UMLS CUI [9,2])
C3850041 (UMLS CUI [10,1])
C0332196 (UMLS CUI [10,2])
C0025605 (UMLS CUI [11,1])
C0205360 (UMLS CUI [11,2])
C0332196 (UMLS CUI [11,3])
Condition At risk Clinical Trial | Condition At risk Patient Health | Condition Preventing Protocol Compliance
Item
any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0018684 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Alcohol consumption At risk Patient safety | Alcohol consumption At risk Protocol Compliance | Suspicion Alcohol consumption | Barbiturates | Suspicion Barbiturates | Amphetamines | Suspicion Amphetamines | Recreational Drugs | Suspicion Recreational Drugs | Narcotic Drugs | Suspicion Narcotic Drugs
Item
history or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the trial procedures
boolean
C0001948 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0001948 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0242114 (UMLS CUI [3,1])
C0001948 (UMLS CUI [3,2])
C0004745 (UMLS CUI [4])
C0242114 (UMLS CUI [5,1])
C0004745 (UMLS CUI [5,2])
C0002667 (UMLS CUI [6])
C0242114 (UMLS CUI [7,1])
C0002667 (UMLS CUI [7,2])
C0242508 (UMLS CUI [8])
C0242114 (UMLS CUI [9,1])
C0242508 (UMLS CUI [9,2])
C0237425 (UMLS CUI [10])
C0242114 (UMLS CUI [11,1])
C0237425 (UMLS CUI [11,2])
Study Subject Participation Status | Clinical Trial | Investigational New Drug | INVESTIGATIONAL VACCINES
Item
participation in an investigational drug trial or having received an investigational vaccine within 30 days prior to the first intake of tmc647055 or placebo.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C1875384 (UMLS CUI [4])