ID
40852
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 Pharmacogenetic Research Form is used to record the state of informed consent for the pharmacogenetic research at the moments when the state changes. See the form sections for more details.
Trefwoorden
Versies (1)
- 26-05-20 26-05-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 mei 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
PGx - Pharmacogenetic Research
- StudyEvent: ODM
Beschrijving
CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
Alias
- UMLS CUI-1
- C0021430
- UMLS CUI-2
- C2347500
Beschrijving
informed consent Pharmacogenetic Test
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
Beschrijving
Pharmacogenetic test Informed consent Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0011008
Beschrijving
Pharmacogenetic test Informed consent Reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0566251
Beschrijving
other reason for no consent for PGx obtained
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0021430
- UMLS CUI [1,4]
- C2347500
- UMLS CUI [1,5]
- C1882120
Beschrijving
BLOOD SAMPLE COLLECTION (DNA)
Alias
- UMLS CUI-1
- C0005834
Beschrijving
Blood Sample Collection Pharmacogenetic research
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C2347500
Beschrijving
Date Blood sample collection Pharmacogenetic research
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C02347500
Beschrijving
WITHDRAWAL OF CONSENT
Alias
- UMLS CUI-1
- C1707492
Beschrijving
BLOOD SAMPLE DESTRUCTION
Alias
- UMLS CUI-1
- C1948029
- UMLS CUI-2
- C0178913
Beschrijving
Blood Sample Destruction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
Beschrijving
Reason Blood sample destruction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1948029
- UMLS CUI [1,3]
- C0178913
Beschrijving
other reason for blood sample destruction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C0178913
Similar models
PGx - Pharmacogenetic Research
- StudyEvent: ODM
C2347500 (UMLS CUI-2)
C2347500 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,4])
C1882120 (UMLS CUI [1,5])
C2347500 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C02347500 (UMLS CUI [1,3])
C0031325 (UMLS CUI [1,2])
C0178913 (UMLS CUI-2)
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,4])