ID
40932
Descripción
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.
Palabras clave
Versiones (1)
- 7/6/20 7/6/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
7 de junio de 2020
DOI
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Licencia
Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Eligibility Criteria
- StudyEvent: ODM
Descripción
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Descripción
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Descripción
Healthy | gender | age
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3898900
- UMLS CUI [2]
- C0079399
- UMLS CUI [3]
- C0001779
Descripción
Body weight | BMI
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005910
- UMLS CUI [2]
- C1305855
Descripción
Non-smoker
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0337672
Descripción
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.
Tipo de datos
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
Descripción
No abnormality of clinical significance on 12-lead ECG time intervals and morphology
Tipo de datos
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
Descripción
Negative urine drug screen
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0920168
Descripción
Informed Consent
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021430
Descripción
Comprehension study protocol | Protocol compliance
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0162340
- UMLS CUI [1,2]
- C2348563
- UMLS CUI [2]
- C0525058
Descripción
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
Definite or suspected personal or family history of adverse reactions or hypersensitivity to casopitant
Tipo de datos
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
Descripción
Gender
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0079399
Descripción
History of alcohol consumption defined in units per day or units per week
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0456683
- UMLS CUI [2]
- C0560579
Descripción
Alcohol abuse | alcohol dependence | substance abuse | substance dependence
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0085762
- UMLS CUI [2]
- C0001973
- UMLS CUI [3]
- C0038586
- UMLS CUI [4]
- C0038580
Descripción
Recent: Non-prescription drugs | vitamins | herbal | dietary supplements | St. John's Wort
Tipo de datos
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
Descripción
Urinary cotinine positive | tobacco use | nicotine-containing products
Tipo de datos
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
Descripción
Recently received prescription medication
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3843193
- UMLS CUI [1,2]
- C0332185
Descripción
Gastro-intestinal | hepatic | peptic ulcer disease | renal disease | any other condition affecting pharmacokinetics
Tipo de datos
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
Descripción
Semi-supine systolic blood pressure | standing systolic blood pressure | diastolic blood pressure | brachial pulse rate
Tipo de datos
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
Descripción
Grapefruit Recent | grapefruit juice Recent
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0995150
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0452456
- UMLS CUI [2,2]
- C0332185
Descripción
Exposure to new chemical entities - count of entities
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0449788
Descripción
Participated in a trial - new chemical entity
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
Descripción
Participated in a trial - any drug
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013227
Descripción
Plasma donation Recent | Blood donation Recent
Tipo de datos
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
Descripción
Total body radiation dose | exposure to significant radiation | x-ray quantity | CT scan quantity | barium meal
Tipo de datos
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
Descripción
Condition Interferes with Assessment of 14C | Condition Interferes with Recovery of 14C
Tipo de datos
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
Descripción
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.
Tipo de datos
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
Descripción
HIV positivity | HBV positivity | HCV positivity
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0019699
- UMLS CUI [2]
- C2748184
- UMLS CUI [3]
- C2748185
Descripción
Urine drug screen positive | Urine alcohol test positive
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0743300
- UMLS CUI [2]
- C1112219
Descripción
Lacks suitability for participation by Judgement of Investigator
Tipo de datos
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])