Healthy Volunteer | Gender | Age
Item
be a healthy male within the age range of 18 to 60 years.
boolean
C1708335 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Informed Consent
Item
voluntarily sign a research ethics committee (rec)-approved informed consent form to participate in the study after all relevant aspects of the study have been explained and discussed with the subject.
boolean
C0021430 (UMLS CUI [1])
Biochemistry Normal | Blood coagulation tests Normal | Hematology procedure Normal | Urinalysis Normal
Item
have biochemistry, coagulation, haematology and urinalysis test results that are within normal, allowable limits (if out-of-range, must be considered clinically significant to be exclusionary) and performed within 21 days of receiving first dose of test material.
boolean
C0428132 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0005790 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0200627 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0042014 (UMLS CUI [4,1])
C0205307 (UMLS CUI [4,2])
Body mass index
Item
have a bmi (body mass index) between 18.0 and 32.0 kg/m2.
boolean
C1305855 (UMLS CUI [1])
HIV Infection Free of | Hepatitis B Free of | Hepatitis C Free of
Item
be clear of any history of hiv and hepatitis b and c.
boolean
C0019693 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
Disease Significant Absent | Laboratory test result abnormal Absent | Laboratory Procedures | Medical History | Physical Examination
Item
have no significant disease or clinically significant abnormal laboratory value as deemed by the investigator on the laboratory evaluations, medical history, or physical exam.
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0022885 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
12 lead ECG Normal | Electrocardiogram abnormal Without Clinical Significance
Item
have a normal 12-lead ecg or an ecg with abnormality considered to be clinically insignificant.
boolean
C0430456 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
Able to communicate Research Personnel | Protocol Compliance
Item
have the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Agreement Barrier Contraception Double
Item
agree to use an acceptable double barrier method for birth control from the screening visit through 3 months after the last dose of test material.
boolean
C0680240 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
Avoidance Grapefruit | Avoidance GRAPEFRUIT JUICE
Item
agree to refrain from consumption of grapefruits and/or grapefruit juice from 7 days prior to day -1 of treatment visit 1 through to the end of subject's final study visit on day 29.
boolean
C0870186 (UMLS CUI [1,1])
C0995150 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C0452456 (UMLS CUI [2,2])
Illness Major Enrollment Unfavorable | Chronic disease Enrollment Unfavorable
Item
subject has had a major illness in the past three months or any significant ongoing chronic medical illness that the investigator would deem unfavourable for enrolment.
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
C3640815 (UMLS CUI [1,4])
C0008679 (UMLS CUI [2,1])
C1516879 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
Renal Insufficiency | Hepatic impairment
Item
subject has renal or liver impairment.
boolean
C1565489 (UMLS CUI [1])
C0948807 (UMLS CUI [2])
Gastrointestinal Surgical Procedure | Gastrointestinal Diseases Influence Drug absorption
Item
subject has a history of gastro-intestinal surgery or has a current gastrointestinal disease which may influence drug absorption.
boolean
C0524722 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0678745 (UMLS CUI [2,3])
Drug abuse | Benzodiazepines | Opioids | Amphetamines | Cocaine | Tetrahydrocannabinol | Drug screen positive
Item
subject has a history, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, and thc) or a positive drug result at the screening visit.
boolean
C0013146 (UMLS CUI [1])
C0005064 (UMLS CUI [2])
C0242402 (UMLS CUI [3])
C0002667 (UMLS CUI [4])
C0009170 (UMLS CUI [5])
C0039663 (UMLS CUI [6])
C0743295 (UMLS CUI [7])
Tobacco use Number of cigarettes per day
Item
subject smokes more than 5 cigarettes a day.
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Alcoholic Intoxication, Chronic | Alcohol consumption Alcoholic Beverages Quantity per day
Item
subject has a history of alcoholism, and/or is currently drinking more than three drinks per day [one drink is equal to one unit of alcohol (one glass of wine, half a pint of beer, one measure of a spirit)].
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0001967 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0439505 (UMLS CUI [2,4])
Study Subject Participation Status | Exception Clinical Trial Specified
Item
subject has participated in a clinical trial within the past three months (defined as three months from the date of last dose of an investigational medicinal product), with the exception of the srt-2104-004 study (eudract number: 2008-007364-41).
boolean
C2348568 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Blood Donation Difficult | Access Via arm vein Difficult
Item
subject has a history of difficulty in donating blood or accessibility of veins in left or right arm.
boolean
C0005794 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C0444454 (UMLS CUI [2,1])
C0442444 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Blood Donation Unit Quantity
Item
subject has donated blood (one unit or 350 ml) within three months prior to receiving test material.
boolean
C0005794 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Plant product | Drugs, Non-Prescription | Pharmacotherapy | Drug half-life Duration
Item
subject is taking herbal products, over-the-counter medication or prescription drug therapy for which 5 times the half-life is longer than 21 days (i.e., the screening period) prior to enrolment into the study.
boolean
C0032088 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0013216 (UMLS CUI [3])
C0678761 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])