Healthy | gender | age
Item
1. Subject is a healthy male aged 30 - 55.
boolean
C3898900 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Body weight | BMI
Item
2. Subject has body weight >50 kg and BMI within the range of 19-30 kg/m2, inclusive.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Non-smoker
Item
3. Subject is a non-smoker (abstinence from smoking for at least 6 months before the start of the study).
boolean
C0337672 (UMLS CUI [1])
No clinically significant findings on: clinical examination | medical examination | clinical chemistry | haematology | urinalysis | (including microscopy, if abnormalities are found) at pre-study.
Item
4. Subject has no clinically relevant findings on clinical examination, medical examination and tests, clinical chemistry, haematology and urinalysis (including microscopy, if abnormalities are found) at pre-study.
boolean
C0559229 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
C0559229 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0582103 (UMLS CUI [2,3])
C0559229 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0008000 (UMLS CUI [3,3])
C0559229 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C0018941 (UMLS CUI [4,3])
C0559229 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0042014 (UMLS CUI [5,3])
C0332257 (UMLS CUI [6,1])
C0430397 (UMLS CUI [6,2])
C1704258 (UMLS CUI [6,3])
No abnormality of clinical significance on 12-lead ECG time intervals and morphology
Item
5. Subject has no clinically relevant findings on 12-lead ECG time intervals and morphology at the prestudy examination.
boolean
C1298908 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
C2215974 (UMLS CUI [1,5])
C1298908 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
C2826293 (UMLS CUI [2,4])
C0332437 (UMLS CUI [2,5])
Negative urine drug screen
Item
6. Subject has a negative urine drug screen at pre-study
boolean
C0920168 (UMLS CUI [1])
Informed Consent
Item
7. Subject has provided a signed and dated written informed consent prior to study participation.
boolean
C0021430 (UMLS CUI [1])
Comprehension study protocol | Protocol compliance
Item
8. Subject is able to understand and comply with the protocol requirements, instructions and restrictions.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Definite or suspected personal or family history of adverse reactions or hypersensitivity to casopitant
Item
1. Subject has a definite or suspected personal or family history of adverse reactions or hypersensitivity to the trial drug or to drugs with a similar chemical structure.
boolean
C0020517 (UMLS CUI [1,1])
C2347566 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C0559546 (UMLS CUI [2,1])
C2347566 (UMLS CUI [2,2])
C0241889 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C2347566 (UMLS CUI [3,2])
C0262926 (UMLS CUI [3,3])
C0559546 (UMLS CUI [4,1])
C2347566 (UMLS CUI [4,2])
C0262926 (UMLS CUI [4,3])
Gender
Item
2. Subject is female.
boolean
C0079399 (UMLS CUI [1])
History of alcohol consumption defined in units per day or units per week
Item
3. Subject has a known or suspected history of alcohol consumption defined as an average daily intake of greater than three units or a weekly intake of more than 21 units (one unit is equivalent to 250 mL beer, a glass of wine or a measure of spirits).
boolean
C0001948 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0560579 (UMLS CUI [2])
Alcohol abuse | alcohol dependence | substance abuse | substance dependence
Item
4. Subject has a history of alcohol/drug abuse or dependence within 12 months of the study.
boolean
C0085762 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
C0038580 (UMLS CUI [4])
Recent: Non-prescription drugs | vitamins | herbal | dietary supplements | St. John's Wort
Item
5. Subject has received non-prescription drugs or vitamins, herbal and dietary supplements within 48 hours prior to the first study day, or St. John's Wort within 14 days prior to the first dose of study drug.
boolean
C0013231 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0042890 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1504473 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0242295 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C0936242 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
Urinary cotinine positive | tobacco use | nicotine-containing products
Item
6. Subject has urinary cotinine levels indicative of smoking at screening or pre-dose, or history of regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
boolean
C1699505 (UMLS CUI [1])
C0543414 (UMLS CUI [2])
C1514468 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0028040 (UMLS CUI [3,3])
Recently received prescription medication
Item
7. Subject has received prescription medications within 14 days.
boolean
C3843193 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Gastro-intestinal | hepatic | peptic ulcer disease | renal disease | any other condition affecting pharmacokinetics
Item
8. Subject has a history or presence of gastro-intestinal, hepatic, peptic ulcer disease or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
boolean
C0017178 (UMLS CUI [1])
C0085605 (UMLS CUI [2])
C0030920 (UMLS CUI [3])
C0035078 (UMLS CUI [4])
C2359476 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0031327 (UMLS CUI [5,3])
Semi-supine systolic blood pressure | standing systolic blood pressure | diastolic blood pressure | brachial pulse rate
Item
9. Subject has a semi-supine and standing systolic blood pressure less than 90mmHg or greater than 150mmHg or a diastolic blood pressure of less than 45mmHg or greater than 90mmHg; or a brachial pulse rate less than 40bpm or more than 90bpm.
boolean
C3828195 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0231472 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3])
C1096531 (UMLS CUI [4])
Grapefruit Recent | grapefruit juice Recent
Item
10. Subject has consumed grapefruit or grapefruit juice within seven days of the first study day.
boolean
C0995150 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0452456 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Exposure to new chemical entities - count of entities
Item
11. Subject has had exposure to more than three new chemical entities within 12 months prior to the first dosing period.
boolean
C0332157 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Participated in a trial - new chemical entity
Item
12. Subject has participated in a trial with a different new chemical entity within 112 days prior to the start of this study.
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Participated in a trial - any drug
Item
13. Subject has participated in a trial with any drug within 84 days before the start of the study.
boolean
C2348568 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Plasma donation Recent | Blood donation Recent
Item
14. Subject has donated plasma within 7 days prior to the screening visit or donated 450 mL of blood within 84 days prior to the start of this study.
boolean
C0032105 (UMLS CUI [1,1])
C0680854 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0005794 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Total body radiation dose | exposure to significant radiation | x-ray quantity | CT scan quantity | barium meal
Item
15. Subject has received a total body radiation dose of greater than 5.0 mSv (upper limit of WHO category II) or exposure to significant radiation (e.g., serial x-ray or CT scans, barium meal, etc.) in the 12 months prior to this study.
boolean
C2919490 (UMLS CUI [1])
C0332157 (UMLS CUI [2,1])
C0034538 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0043309 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0040405 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0203065 (UMLS CUI [5])
Condition Interferes with Assessment of 14C | Condition Interferes with Recovery of 14C
Item
16.Subject has any condition that could interfere with the accurate assessment and recovery of 14C.
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C0302945 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237820 (UMLS CUI [2,3])
C0302945 (UMLS CUI [2,4])
Sexual abstinence unwilling | Condom use Unwilling | Partner Contraception Unwilling
Item
17. Subject is a male who is attempting to father a child during and up to 90 days after the trial.
boolean
C0036899 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0679782 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0682323 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
HIV positivity | HBV positivity | HCV positivity
Item
18.Subject is positive for HIV, hepatitis B virus or hepatitis C virus assays at screening.
boolean
C0019699 (UMLS CUI [1])
C2748184 (UMLS CUI [2])
C2748185 (UMLS CUI [3])
Urine drug screen positive | Urine alcohol test positive
Item
19. Subject has positive urine drug screen including alcohol at screening or pre-dose.
boolean
C0743300 (UMLS CUI [1])
C1112219 (UMLS CUI [2])
Lacks suitability for participation by Judgement of Investigator
Item
20. Subject lacks suitability for participation in this study, for any reason, in the opinion of the investigator.
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
C0008961 (UMLS CUI [1,4])