ID

40852

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 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.

Palabras clave

Versiones (1)
  1. 26/5/20 26/5/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

26 de mayo 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

Inglés

PGx - Pharmacogenetic Research

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
Descripción

CONSENT FOR PGx-PHARMACOGENETIC RESEARCH

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
Has informed consent been obtained for PGx-Pharmacogenetic research?
Descripción

informed consent Pharmacogenetic Test

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
Descripción

Pharmacogenetic test Informed consent Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
If No, check one reason:
Descripción

Pharmacogenetic test Informed consent Reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0566251
Other, specify
Descripción

other reason for no consent for PGx obtained

Tipo de datos

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
BLOOD SAMPLE COLLECTION (DNA)
Descripción

BLOOD SAMPLE COLLECTION (DNA)

Alias
UMLS CUI-1
C0005834
Has a blood sample been collected for PGx-pharmacogenetic research?
Descripción

Blood Sample Collection Pharmacogenetic research

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C2347500
If Yes, record the date sample taken
Descripción

Date Blood sample collection Pharmacogenetic research

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C02347500
WITHDRAWAL OF CONSENT
Descripción

WITHDRAWAL OF CONSENT

Alias
UMLS CUI-1
C1707492
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Descripción

Withdrawal of consent Pharmacogenetic research

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
BLOOD SAMPLE DESTRUCTION
Descripción

BLOOD SAMPLE DESTRUCTION

Alias
UMLS CUI-1
C1948029
UMLS CUI-2
C0178913
Has a request been made for sample destruction?
Descripción

Blood Sample Destruction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
If Yes, check one reason:
Descripción

Reason Blood sample destruction

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
If other, please specify
Descripción

other reason for blood sample destruction

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C0178913
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Similar models

PGx - Pharmacogenetic Research

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
informed consent Pharmacogenetic Test
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Pharmacogenetic test Informed consent Date
Item
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If No, check one reason:
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
reason
Code List
If No, check one reason:
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (Z)
other reason for no consent for PGx obtained
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,4])
C1882120 (UMLS CUI [1,5])
Item Group
BLOOD SAMPLE COLLECTION (DNA)
C0005834 (UMLS CUI-1)
Blood Sample Collection Pharmacogenetic research
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
boolean
C0005834 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Date Blood sample collection Pharmacogenetic research
Item
If Yes, record the date sample taken
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C02347500 (UMLS CUI [1,3])
Item Group
WITHDRAWAL OF CONSENT
C1707492 (UMLS CUI-1)
Withdrawal of consent Pharmacogenetic research
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Item Group
BLOOD SAMPLE DESTRUCTION
C1948029 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
Blood Sample Destruction
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item
If Yes, check one reason:
text
C0392360 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
reason BLOOD SAMPLE DESTRUCTION
Code List
If Yes, check one reason:
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (Z)
other reason for blood sample destruction
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,4])
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