ID
40932
Beschrijving
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.
Trefwoorden
Versies (1)
- 07-06-20 07-06-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
7 juni 2020
DOI
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Licentie
Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Eligibility Criteria
- StudyEvent: ODM
Beschrijving
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Healthy | gender | age
Datatype
boolean
Alias
- UMLS CUI [1]
- C3898900
- UMLS CUI [2]
- C0079399
- UMLS CUI [3]
- C0001779
Beschrijving
Body weight | BMI
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005910
- UMLS CUI [2]
- C1305855
Beschrijving
Non-smoker
Datatype
boolean
Alias
- UMLS CUI [1]
- C0337672
Beschrijving
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.
Datatype
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
Beschrijving
No abnormality of clinical significance on 12-lead ECG time intervals and morphology
Datatype
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
Beschrijving
Negative urine drug screen
Datatype
boolean
Alias
- UMLS CUI [1]
- C0920168
Beschrijving
Informed Consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Comprehension study protocol | Protocol compliance
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0162340
- UMLS CUI [1,2]
- C2348563
- UMLS CUI [2]
- C0525058
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Definite or suspected personal or family history of adverse reactions or hypersensitivity to casopitant
Datatype
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
Beschrijving
Gender
Datatype
boolean
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
History of alcohol consumption defined in units per day or units per week
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0456683
- UMLS CUI [2]
- C0560579
Beschrijving
Alcohol abuse | alcohol dependence | substance abuse | substance dependence
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085762
- UMLS CUI [2]
- C0001973
- UMLS CUI [3]
- C0038586
- UMLS CUI [4]
- C0038580
Beschrijving
Recent: Non-prescription drugs | vitamins | herbal | dietary supplements | St. John's Wort
Datatype
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
Beschrijving
Urinary cotinine positive | tobacco use | nicotine-containing products
Datatype
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
Beschrijving
Recently received prescription medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3843193
- UMLS CUI [1,2]
- C0332185
Beschrijving
Gastro-intestinal | hepatic | peptic ulcer disease | renal disease | any other condition affecting pharmacokinetics
Datatype
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
Beschrijving
Semi-supine systolic blood pressure | standing systolic blood pressure | diastolic blood pressure | brachial pulse rate
Datatype
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
Beschrijving
Grapefruit Recent | grapefruit juice Recent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0995150
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0452456
- UMLS CUI [2,2]
- C0332185
Beschrijving
Exposure to new chemical entities - count of entities
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0449788
Beschrijving
Participated in a trial - new chemical entity
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
Beschrijving
Participated in a trial - any drug
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013227
Beschrijving
Plasma donation Recent | Blood donation Recent
Datatype
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
Beschrijving
Total body radiation dose | exposure to significant radiation | x-ray quantity | CT scan quantity | barium meal
Datatype
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
Beschrijving
Condition Interferes with Assessment of 14C | Condition Interferes with Recovery of 14C
Datatype
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
Beschrijving
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.
Datatype
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
Beschrijving
HIV positivity | HBV positivity | HCV positivity
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019699
- UMLS CUI [2]
- C2748184
- UMLS CUI [3]
- C2748185
Beschrijving
Urine drug screen positive | Urine alcohol test positive
Datatype
boolean
Alias
- UMLS CUI [1]
- C0743300
- UMLS CUI [2]
- C1112219
Beschrijving
Lacks suitability for participation by Judgement of Investigator
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1512714
- UMLS CUI [1,3]
- C0022423
- UMLS CUI [1,4]
- C0008961
Similar models
Eligibility Criteria
- StudyEvent: ODM
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C1305855 (UMLS CUI [2])
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])
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])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
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])
C0456683 (UMLS CUI [1,2])
C0560579 (UMLS CUI [2])
C0001973 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
C0038580 (UMLS CUI [4])
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])
C0543414 (UMLS CUI [2])
C1514468 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0028040 (UMLS CUI [3,3])
C0332185 (UMLS CUI [1,2])
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])
C0871470 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0231472 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3])
C1096531 (UMLS CUI [4])
C0332185 (UMLS CUI [1,2])
C0452456 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0304229 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0680854 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0005794 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
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])
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])
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])
C2748184 (UMLS CUI [2])
C2748185 (UMLS CUI [3])
C1112219 (UMLS CUI [2])
C1512714 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
C0008961 (UMLS CUI [1,4])