ID
40932
Beschreibung
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.
Stichworte
Versionen (1)
- 07.06.20 07.06.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
7. Juni 2020
DOI
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Lizenz
Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Eligibility Criteria
- StudyEvent: ODM
Beschreibung
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
Healthy | gender | age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3898900
- UMLS CUI [2]
- C0079399
- UMLS CUI [3]
- C0001779
Beschreibung
Body weight | BMI
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005910
- UMLS CUI [2]
- C1305855
Beschreibung
Non-smoker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0337672
Beschreibung
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.
Datentyp
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
Beschreibung
No abnormality of clinical significance on 12-lead ECG time intervals and morphology
Datentyp
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
Beschreibung
Negative urine drug screen
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0920168
Beschreibung
Informed Consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Comprehension study protocol | Protocol compliance
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0162340
- UMLS CUI [1,2]
- C2348563
- UMLS CUI [2]
- C0525058
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Definite or suspected personal or family history of adverse reactions or hypersensitivity to casopitant
Datentyp
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
Beschreibung
Gender
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
History of alcohol consumption defined in units per day or units per week
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0456683
- UMLS CUI [2]
- C0560579
Beschreibung
Alcohol abuse | alcohol dependence | substance abuse | substance dependence
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085762
- UMLS CUI [2]
- C0001973
- UMLS CUI [3]
- C0038586
- UMLS CUI [4]
- C0038580
Beschreibung
Recent: Non-prescription drugs | vitamins | herbal | dietary supplements | St. John's Wort
Datentyp
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
Beschreibung
Urinary cotinine positive | tobacco use | nicotine-containing products
Datentyp
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
Beschreibung
Recently received prescription medication
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3843193
- UMLS CUI [1,2]
- C0332185
Beschreibung
Gastro-intestinal | hepatic | peptic ulcer disease | renal disease | any other condition affecting pharmacokinetics
Datentyp
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
Beschreibung
Semi-supine systolic blood pressure | standing systolic blood pressure | diastolic blood pressure | brachial pulse rate
Datentyp
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
Beschreibung
Grapefruit Recent | grapefruit juice Recent
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0995150
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0452456
- UMLS CUI [2,2]
- C0332185
Beschreibung
Exposure to new chemical entities - count of entities
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0449788
Beschreibung
Participated in a trial - new chemical entity
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
Beschreibung
Participated in a trial - any drug
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013227
Beschreibung
Plasma donation Recent | Blood donation Recent
Datentyp
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
Beschreibung
Total body radiation dose | exposure to significant radiation | x-ray quantity | CT scan quantity | barium meal
Datentyp
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
Beschreibung
Condition Interferes with Assessment of 14C | Condition Interferes with Recovery of 14C
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
HIV positivity | HBV positivity | HCV positivity
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019699
- UMLS CUI [2]
- C2748184
- UMLS CUI [3]
- C2748185
Beschreibung
Urine drug screen positive | Urine alcohol test positive
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0743300
- UMLS CUI [2]
- C1112219
Beschreibung
Lacks suitability for participation by Judgement of Investigator
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1512714
- UMLS CUI [1,3]
- C0022423
- UMLS CUI [1,4]
- C0008961
Ähnliche Modelle
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])