ID

41684

Beschrijving

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Trefwoorden

Versies (1)
  1. 15-12-20 15-12-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

15 december 2020

DOI

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Licentie

Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

Engels

Pharmacogenetic Research

1 Formulieren  
Date of Visit
Beschrijving

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Beschrijving

Date of Visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Pharmacogenetic Research Content
Beschrijving

Pharmacogenetic Research Content

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

Has informed consent been obtained for PGx-Pharmacogenetic research

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
Record date informed consent obtained for PGx Pharmacogenetic research
Beschrijving

Record date informed consent obtained for PGx Pharmacogenetic research

Datatype

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Beschrijving

Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
Date sample taken
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
If informed consent has not been obtained, check reason
Beschrijving

If informed consent has not been obtained, check reason

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0566251
Specify other reason for consent has not been obtained
Beschrijving

Specify other reason for consent has not been obtained

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [2,1]
C0566251
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348235
Pharmacogenetic Research Withdrawal of Consent
Beschrijving

Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C0031325
Has subject withdrawn consent for PGx research?
Beschrijving

Has subject withdrawn consent for PGx research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
Has a request been made for sample destruction?
Beschrijving

Has a request been made for sample destruction?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
Record reason for request been made for sample destruction
Beschrijving

Record reason for request been made for sample destruction

Datatype

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
Specify other reason for request been made for sample destruction
Beschrijving

Specify other reason for request been made for sample destruction

Datatype

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C0205394
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Similar models

Pharmacogenetic Research

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Pharmacogenetic Research Content
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Has informed consent been obtained for PGx-Pharmacogenetic research
Item
Has informed consent been obtained for PGx-Pharmacogenetic research
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Record date informed consent obtained for PGx Pharmacogenetic research
Item
Record date informed consent obtained for PGx Pharmacogenetic research
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Item
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
If informed consent has not been obtained, check reason
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
If informed consent has not been obtained, check reason
Code List
If informed consent has not been obtained, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (Z)
Specify other reason for consent has not been obtained
Item
Specify other reason for consent has not been obtained
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0566251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Item Group
Pharmacogenetic Research Withdrawal of Consent
C1707492 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
Has subject withdrawn consent for PGx research?
Item
Has subject withdrawn consent for PGx research?
boolean
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
Record reason for request been made for sample destruction
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Record reason for request been made for sample destruction
Code List
Record reason for request been made for sample destruction
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other, specify (Z)
Specify other reason for request been made for sample destruction
Item
Specify other reason for request been made for sample destruction
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
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