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41684

Descrizione

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

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versioni (1)
  1. 15/12/20 15/12/20 -
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GlaxoSmithKline

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15 dicembre 2020

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

    Inglese

    Pharmacogenetic Research

    1 moduli  
    Date of Visit
    Descrizione

    Date of Visit

    Alias
    UMLS CUI-1
    C1320303
    Date of Visit
    Descrizione

    Date of Visit

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1320303
    Pharmacogenetic Research Content
    Descrizione

    Pharmacogenetic Research Content

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

    Has informed consent been obtained for PGx-Pharmacogenetic research

    Tipo di dati

    boolean

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

    Record date informed consent obtained for PGx Pharmacogenetic research

    Tipo di dati

    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?
    Descrizione

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

    Tipo di dati

    boolean

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

    Date sample taken

    Tipo di dati

    date

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

    If informed consent has not been obtained, check reason

    Tipo di dati

    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
    Descrizione

    Specify other reason for consent has not been obtained

    Tipo di dati

    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
    Descrizione

    Pharmacogenetic Research Withdrawal of Consent

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    Has subject withdrawn consent for PGx research?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

    Has subject withdrawn consent for PGx research?

    Tipo di dati

    boolean

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

    Has a request been made for sample destruction?

    Tipo di dati

    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
    Descrizione

    Record reason for request been made for sample destruction

    Tipo di dati

    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
    Descrizione

    Specify other reason for request been made for sample destruction

    Tipo di dati

    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
    Ritorna all'inizio della pagina

    Similar models

    Pharmacogenetic Research

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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])
    Ritorna all'inizio della pagina 

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