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ID

43945

Descrizione

A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.; ODM derived from: https://clinicaltrials.gov/show/NCT01928368

collegamento

https://clinicaltrials.gov/show/NCT01928368

Keywords

versioni (2)
  1. 31/03/16 31/03/16 -
  2. 20/09/21 20/09/21 -
Caricato su

20 settembre 2021

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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    Eligibility Asthma NCT01928368

    Inglese

    Eligibility Asthma NCT01928368

    1 moduli  
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT01928368
    Criteria
    Descrizione

    Criteria

    is a current non-smoker, has not used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months, and cumulative smoking history is ≤10 pack years.
    Descrizione

    Non-smoker

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0337672
    UMLS CUI [2]
    C0037390
    UMLS CUI [3]
    C0008038
    UMLS CUI [4]
    C0678446
    UMLS CUI [5]
    C0677453
    UMLS CUI [6]
    C0240766
    UMLS CUI [7]
    C0358855
    UMLS CUI [8]
    C2230126
    females must be of documented non-reproductive potential (ie, postmenopausal [see definition below]; or history of hysterectomy; or history of bilateral salpingectomy; or history of bilateral oophorectomy).
    Descrizione

    Female | Postmenopausal state | Hysterectomy | bilateral salpingectomy | Bilateral oophorectomy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0086287
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0232970
    UMLS CUI [3]
    C0020699
    UMLS CUI [4]
    C2243030
    UMLS CUI [5]
    C0278321
    body mass index (bmi) between ≥ 18.0 and ≤ 32.0 kg/m2 at screening. (subjects with mild atopic asthma only)
    Descrizione

    Mild allergic asthma | Body mass index

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C4040757
    UMLS CUI [2]
    C1305855
    documented history of mild, stable atopic asthma within 2 years of screening.
    Descrizione

    Mild allergic asthma | Stable status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C4040757
    UMLS CUI [1,2]
    C0205360
    has used only inhaled short-acting β2-agonists (less than twice weekly) to treat asthma.
    Descrizione

    Therapeutic procedure | Asthma | Adrenergic beta-2 Receptor Agonists

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0004096
    UMLS CUI [2]
    C2936789
    pre-bronchodilator forced expiratory volume in 1 second (fev1) > 70 percent predicted at screening.
    Descrizione

    FEV1 | pre-bronchodilator

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0748133
    UMLS CUI [1,2]
    C2599602
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    (all subjects)
    Descrizione

    ID.7

    Tipo di dati

    boolean

    history or evidence of a clinically significant disorder, condition or disease that, in the opinion of the principal investigator or amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
    Descrizione

    Disease | Study Subject Participation Status | Limited

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0012634
    UMLS CUI [2,1]
    C2348568
    UMLS CUI [2,2]
    C0439801
    subject has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or subject has a positive purified protein derivative (ppd) or quantiferon test at screening. subjects with a documented negative ppd or quantiferon test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening.
    Descrizione

    Exposure to tuberculosis | positive purified protein derivative (ppd) | Quantiferon test

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0149796
    UMLS CUI [2]
    C0199176
    UMLS CUI [3]
    C0032739
    UMLS CUI [4,1]
    C1875713
    UMLS CUI [4,2]
    C0392366
    has donated or lost ≥ 500 ml of blood or plasma within 8 weeks of administration of the first dose of ip.
    Descrizione

    Blood Donation | Blood Loss | Immunoprecipitation

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0005794
    UMLS CUI [2]
    C3163616
    UMLS CUI [3]
    C0021069
    other criteria may apply.
    Descrizione

    Other criteria

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0205394
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    Similar models

    Eligibility Asthma NCT01928368

    1 moduli
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT01928368
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Non-smoker
    Item
    is a current non-smoker, has not used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months, and cumulative smoking history is ≤10 pack years.
    boolean
    C0337672 (UMLS CUI [1])
    C0037390 (UMLS CUI [2])
    C0008038 (UMLS CUI [3])
    C0678446 (UMLS CUI [4])
    C0677453 (UMLS CUI [5])
    C0240766 (UMLS CUI [6])
    C0358855 (UMLS CUI [7])
    C2230126 (UMLS CUI [8])
    Female | Postmenopausal state | Hysterectomy | bilateral salpingectomy | Bilateral oophorectomy
    Item
    females must be of documented non-reproductive potential (ie, postmenopausal [see definition below]; or history of hysterectomy; or history of bilateral salpingectomy; or history of bilateral oophorectomy).
    boolean
    C0086287 (UMLS CUI [1])
    C3831118 (UMLS CUI [2,1])
    C0232970 (UMLS CUI [2,2])
    C0020699 (UMLS CUI [3])
    C2243030 (UMLS CUI [4])
    C0278321 (UMLS CUI [5])
    Mild allergic asthma | Body mass index
    Item
    body mass index (bmi) between ≥ 18.0 and ≤ 32.0 kg/m2 at screening. (subjects with mild atopic asthma only)
    boolean
    C4040757 (UMLS CUI [1])
    C1305855 (UMLS CUI [2])
    Mild allergic asthma | Stable status
    Item
    documented history of mild, stable atopic asthma within 2 years of screening.
    boolean
    C4040757 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    Therapeutic procedure | Asthma | Adrenergic beta-2 Receptor Agonists
    Item
    has used only inhaled short-acting β2-agonists (less than twice weekly) to treat asthma.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0004096 (UMLS CUI [1,2])
    C2936789 (UMLS CUI [2])
    FEV1 | pre-bronchodilator
    Item
    pre-bronchodilator forced expiratory volume in 1 second (fev1) > 70 percent predicted at screening.
    boolean
    C0748133 (UMLS CUI [1,1])
    C2599602 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    ID.7
    Item
    (all subjects)
    boolean
    Disease | Study Subject Participation Status | Limited
    Item
    history or evidence of a clinically significant disorder, condition or disease that, in the opinion of the principal investigator or amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
    boolean
    C0012634 (UMLS CUI [1])
    C2348568 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])
    Exposure to tuberculosis | positive purified protein derivative (ppd) | Quantiferon test
    Item
    subject has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or subject has a positive purified protein derivative (ppd) or quantiferon test at screening. subjects with a documented negative ppd or quantiferon test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening.
    boolean
    C0149796 (UMLS CUI [1])
    C0199176 (UMLS CUI [2])
    C0032739 (UMLS CUI [3])
    C1875713 (UMLS CUI [4,1])
    C0392366 (UMLS CUI [4,2])
    Blood Donation | Blood Loss | Immunoprecipitation
    Item
    has donated or lost ≥ 500 ml of blood or plasma within 8 weeks of administration of the first dose of ip.
    boolean
    C0005794 (UMLS CUI [1])
    C3163616 (UMLS CUI [2])
    C0021069 (UMLS CUI [3])
    Other criteria
    Item
    other criteria may apply.
    boolean
    C0205394 (UMLS CUI [1])
    Ritorna all'inizio della pagina 

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