ID

40932

Description

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Eligibility Criteria Form has to be filled in at the screening visit. It determines the eligibility of the subject to participate in the study. Confirm that the subject is eligible to participate in the study and if not, that all the failed criteria have been marked.

Keywords

Versions (1)
  1. 6/7/20 6/7/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 7, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

English

Eligibility Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Description

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Subject is a healthy male aged 30 - 55.
Description

Healthy | gender | age

Data type

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
2. Subject has body weight >50 kg and BMI within the range of 19-30 kg/m2, inclusive.
Description

Body weight | BMI

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
3. Subject is a non-smoker (abstinence from smoking for at least 6 months before the start of the study).
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
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.
Description

Note: If parameters are outside the normal range, the subject may nevertheless participate in the study when, in the opinion of the Principal Investigator or designee, the abnormality will not compromise safety or interfere with study procedure.

Data type

boolean

Alias
UMLS CUI [1,1]
C0559229
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C1456356
UMLS CUI [2,1]
C0559229
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0582103
UMLS CUI [3,1]
C0559229
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C0008000
UMLS CUI [4,1]
C0559229
UMLS CUI [4,2]
C2826293
UMLS CUI [4,3]
C0018941
UMLS CUI [5,1]
C0559229
UMLS CUI [5,2]
C2826293
UMLS CUI [5,3]
C0042014
UMLS CUI [6,1]
C0332257
UMLS CUI [6,2]
C0430397
UMLS CUI [6,3]
C1704258
5. Subject has no clinically relevant findings on 12-lead ECG time intervals and morphology at the prestudy examination.
Description

No abnormality of clinical significance on 12-lead ECG time intervals and morphology

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0430456
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2826293
UMLS CUI [1,5]
C2215974
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C0430456
UMLS CUI [2,3]
C1704258
UMLS CUI [2,4]
C2826293
UMLS CUI [2,5]
C0332437
6. Subject has a negative urine drug screen at pre-study
Description

Negative urine drug screen

Data type

boolean

Alias
UMLS CUI [1]
C0920168
7. Subject has provided a signed and dated written informed consent prior to study participation.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
8. Subject is able to understand and comply with the protocol requirements, instructions and restrictions.
Description

Comprehension study protocol | Protocol compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
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.
Description

Definite or suspected personal or family history of adverse reactions or hypersensitivity to casopitant

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2347566
UMLS CUI [1,3]
C0241889
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C2347566
UMLS CUI [2,3]
C0241889
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2347566
UMLS CUI [3,3]
C0262926
UMLS CUI [4,1]
C0559546
UMLS CUI [4,2]
C2347566
UMLS CUI [4,3]
C0262926
2. Subject is female.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
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).
Description

History of alcohol consumption defined in units per day or units per week

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0456683
UMLS CUI [2]
C0560579
4. Subject has a history of alcohol/drug abuse or dependence within 12 months of the study.
Description

Alcohol abuse | alcohol dependence | substance abuse | substance dependence

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0001973
UMLS CUI [3]
C0038586
UMLS CUI [4]
C0038580
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.
Description

Recent: Non-prescription drugs | vitamins | herbal | dietary supplements | St. John's Wort

Data type

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0042890
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C1504473
UMLS CUI [3,2]
C0332185
UMLS CUI [4,1]
C0242295
UMLS CUI [4,2]
C0332185
UMLS CUI [5,1]
C0936242
UMLS CUI [5,2]
C0332185
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.
Description

Urinary cotinine positive | tobacco use | nicotine-containing products

Data type

boolean

Alias
UMLS CUI [1]
C1699505
UMLS CUI [2]
C0543414
UMLS CUI [3,1]
C1514468
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0028040
7. Subject has received prescription medications within 14 days.
Description

Recently received prescription medication

Data type

boolean

Alias
UMLS CUI [1,1]
C3843193
UMLS CUI [1,2]
C0332185
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.
Description

Gastro-intestinal | hepatic | peptic ulcer disease | renal disease | any other condition affecting pharmacokinetics

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0085605
UMLS CUI [3]
C0030920
UMLS CUI [4]
C0035078
UMLS CUI [5,1]
C2359476
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0031327
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.
Description

Semi-supine systolic blood pressure | standing systolic blood pressure | diastolic blood pressure | brachial pulse rate

Data type

boolean

Alias
UMLS CUI [1,1]
C3828195
UMLS CUI [1,2]
C0871470
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0231472
UMLS CUI [3]
C0428883
UMLS CUI [4]
C1096531
10. Subject has consumed grapefruit or grapefruit juice within seven days of the first study day.
Description

Grapefruit Recent | grapefruit juice Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0995150
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0452456
UMLS CUI [2,2]
C0332185
11. Subject has had exposure to more than three new chemical entities within 12 months prior to the first dosing period.
Description

Exposure to new chemical entities - count of entities

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0449788
12. Subject has participated in a trial with a different new chemical entity within 112 days prior to the start of this study.
Description

Participated in a trial - new chemical entity

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
13. Subject has participated in a trial with any drug within 84 days before the start of the study.
Description

Participated in a trial - any drug

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013227
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.
Description

Plasma donation Recent | Blood donation Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0680854
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C0332185
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.
Description

Total body radiation dose | exposure to significant radiation | x-ray quantity | CT scan quantity | barium meal

Data type

boolean

Alias
UMLS CUI [1]
C2919490
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0034538
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0043309
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0040405
UMLS CUI [4,2]
C1265611
UMLS CUI [5]
C0203065
16.Subject has any condition that could interfere with the accurate assessment and recovery of 14C.
Description

Condition Interferes with Assessment of 14C | Condition Interferes with Recovery of 14C

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0242485
UMLS CUI [1,4]
C0302945
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237820
UMLS CUI [2,4]
C0302945
17. Subject is a male who is attempting to father a child during and up to 90 days after the trial.
Description

Note: An unwillingness of male subjects to abstain from sexual intercourse or an unwillingness of the subject to use a condom in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation from the time of the first dose of the study medication until 90 days post-dose.

Data type

boolean

Alias
UMLS CUI [1,1]
C0036899
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0679782
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
18.Subject is positive for HIV, hepatitis B virus or hepatitis C virus assays at screening.
Description

HIV positivity | HBV positivity | HCV positivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C2748184
UMLS CUI [3]
C2748185
19. Subject has positive urine drug screen including alcohol at screening or pre-dose.
Description

Urine drug screen positive | Urine alcohol test positive

Data type

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C1112219
20. Subject lacks suitability for participation in this study, for any reason, in the opinion of the investigator.
Description

Lacks suitability for participation by Judgement of Investigator

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C0022423
UMLS CUI [1,4]
C0008961
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Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Eligibility criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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])
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