ID
40852
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 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.
Keywords
Versions (1)
- 5/26/20 5/26/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 26, 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
PGx - Pharmacogenetic Research
- StudyEvent: ODM
Description
CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
Alias
- UMLS CUI-1
- C0021430
- UMLS CUI-2
- C2347500
Description
informed consent Pharmacogenetic Test
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
Description
Pharmacogenetic test Informed consent Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0011008
Description
Pharmacogenetic test Informed consent Reason
Data type
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0566251
Description
other reason for no consent for PGx obtained
Data type
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
Description
BLOOD SAMPLE COLLECTION (DNA)
Alias
- UMLS CUI-1
- C0005834
Description
Blood Sample Collection Pharmacogenetic research
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C2347500
Description
Date Blood sample collection Pharmacogenetic research
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C02347500
Description
WITHDRAWAL OF CONSENT
Alias
- UMLS CUI-1
- C1707492
Description
BLOOD SAMPLE DESTRUCTION
Alias
- UMLS CUI-1
- C1948029
- UMLS CUI-2
- C0178913
Description
Blood Sample Destruction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
Description
Reason Blood sample destruction
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1948029
- UMLS CUI [1,3]
- C0178913
Description
other reason for blood sample destruction
Data type
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])