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ID

40396

Description

Study ID: 111314 Clinical Study ID: 111314 Study Title: A first-time-in-human, three-part, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00857883 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1521498 or placebo Study Indication: Obesity

Mots-clés

Versions (1)
  1. 18/04/2020 18/04/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

18 avril 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0
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    Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883

    Anglais

    Breakfast; Ad-Lib snack total; Cotinine Test; Energy Intake Ad-Lib snack

    1 Formulaires  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Study
    Description

    Study

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2603343
    Subject
    Description

    Subject

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0681850
    Collected by
    Description

    Collected by

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3244127
    Subject Number
    Description

    Subject Number

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585
    Study Phase
    Description

    Study Phase

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0205390
    UMLS CUI [1,2]
    C2603343
    Session
    Description

    Session

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1883017
    Breakfast
    Description

    Breakfast

    Alias
    UMLS CUI-1
    C2698559
    Breakfast - Physical Date
    Description

    Breakfast - Physical Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0011008
    Breakfast - Time
    Description

    Breakfast - Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0040223
    Breakfast - Day
    Description

    Breakfast - Day

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0439228
    Breakfast - Hour
    Description

    Breakfast - Hour

    Type de données

    integer

    Unités de mesure
    • h
    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0439227
    h
    Breakfast - Min
    Description

    Breakfast - Min

    Type de données

    integer

    Unités de mesure
    • min
    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0439232
    min
    Breakfast Start Time
    Description

    Breakfast Start Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C2698559
    Breakfast Stop Time
    Description

    Breakfast Stop Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0444930
    Ad-Lib snack total
    Description

    Ad-Lib snack total

    Alias
    UMLS CUI-1
    C0453863
    UMLS CUI-2
    C0439810
    Ad-Lib snack total - Physical Date
    Description

    Ad-Lib snack total - Physical Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0453863
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [1,3]
    C0011008
    Ad-Lib snack total - Time
    Description

    Ad-Lib snack total - Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C0453863
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [1,3]
    C0040223
    Ad-Lib snack total - Day
    Description

    Ad-Lib snack total - Day

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0453863
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [1,3]
    C0439228
    Ad-Lib snack total - Hour
    Description

    Ad-Lib snack total - Hour

    Type de données

    integer

    Unités de mesure
    • h
    Alias
    UMLS CUI [1,1]
    C0453863
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [1,3]
    C0439227
    h
    Ad-Lib snack total - Min
    Description

    Ad-Lib snack total - Min

    Type de données

    integer

    Unités de mesure
    • min
    Alias
    UMLS CUI [1,1]
    C0453863
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [1,3]
    C0439232
    min
    Ad-Lib snack total - Total High fat/High Sugar
    Description

    Ad-Lib snack total - Total High fat/High Sugar

    Type de données

    integer

    Unités de mesure
    • kcal
    Alias
    UMLS CUI [1,1]
    C0453863
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [2,1]
    C0012171
    UMLS CUI [2,2]
    C0205250
    UMLS CUI [3,1]
    C0242209
    UMLS CUI [3,2]
    C0205250
    kcal
    Ad-Lib snack total - Total High fat/Low Sugar
    Description

    Ad-Lib snack total - Total High fat/Low Sugar

    Type de données

    integer

    Unités de mesure
    • kcal
    Alias
    UMLS CUI [1,1]
    C0453863
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [2,1]
    C0012171
    UMLS CUI [2,2]
    C0205250
    UMLS CUI [3,1]
    C0242209
    UMLS CUI [3,2]
    C0205251
    kcal
    Ad-Lib snack total - Low fat/High Sugar
    Description

    Ad-Lib snack total - Low fat/High Sugar

    Type de données

    integer

    Unités de mesure
    • kcal
    Alias
    UMLS CUI [1,1]
    C0453863
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [2,1]
    C0012171
    UMLS CUI [2,2]
    C0205251
    UMLS CUI [3,1]
    C0242209
    UMLS CUI [3,2]
    C0205250
    kcal
    Ad-Lib snack total - Low fat/Low Sugar
    Description

    Ad-Lib snack total - Low fat/Low Sugar

    Type de données

    integer

    Unités de mesure
    • kcal
    Alias
    UMLS CUI [1,1]
    C0453863
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [2,1]
    C0012171
    UMLS CUI [2,2]
    C0205251
    UMLS CUI [3,1]
    C0242209
    UMLS CUI [3,2]
    C0205251
    kcal
    Cotinine Test
    Description

    Cotinine Test

    Alias
    UMLS CUI-1
    C0202363
    Cotinine Test - Physical Date
    Description

    Cotinine Test - Physical Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0202363
    UMLS CUI [1,2]
    C0011008
    Cotinine Test - Time
    Description

    Cotinine Test - Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C0202363
    UMLS CUI [1,2]
    C0040223
    Cotinine Test - Day
    Description

    Cotinine Test - Day

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0202363
    UMLS CUI [1,2]
    C0439228
    Cotinine Test - Hour
    Description

    Cotinine Test - Hour

    Type de données

    integer

    Unités de mesure
    • h
    Alias
    UMLS CUI [1,1]
    C0202363
    UMLS CUI [1,2]
    C0439227
    h
    Cotinine Test - Min
    Description

    Cotinine Test - Min

    Type de données

    integer

    Unités de mesure
    • min
    Alias
    UMLS CUI [1,1]
    C0202363
    UMLS CUI [1,2]
    C0439232
    min
    Cotinine Test - Date of Test
    Description

    Cotinine Test - Date of Test

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0202363
    UMLS CUI [1,2]
    C0011008
    Cotinine Test - Time of Test
    Description

    Cotinine Test - Time of Test

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C0202363
    UMLS CUI [1,2]
    C0040223
    Cotinine Test - Result
    Description

    Cotinine Test - Result

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0202363
    UMLS CUI [1,2]
    C1274040
    Energy intake ad-lib snack
    Description

    Energy intake ad-lib snack

    Alias
    UMLS CUI-1
    C0006777
    UMLS CUI-2
    C0453863
    Energy intake ad-lib snack - Physical Date
    Description

    Energy intake ad-lib snack - Physical Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0006777
    UMLS CUI [1,2]
    C0453863
    UMLS CUI [1,3]
    C0011008
    Energy intake ad-lib snack - Time
    Description

    Energy intake ad-lib snack - Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C0006777
    UMLS CUI [1,2]
    C0453863
    UMLS CUI [1,3]
    C0011008
    Energy intake ad-lib snack - Day
    Description

    Energy intake ad-lib snack - Day

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0006777
    UMLS CUI [1,2]
    C0453863
    UMLS CUI [1,3]
    C0439228
    Energy intake ad-lib snack - Hour
    Description

    Energy intake ad-lib snack - Hour

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0006777
    UMLS CUI [1,2]
    C0453863
    UMLS CUI [1,3]
    C0439227
    Energy intake ad-lib snack - Min
    Description

    Energy intake ad-lib snack - Min

    Type de données

    integer

    Unités de mesure
    • min
    Alias
    UMLS CUI [1,1]
    C0006777
    UMLS CUI [1,2]
    C0453863
    UMLS CUI [1,3]
    C0439232
    min
    Energy intake
    Description

    Energy intake

    Alias
    UMLS CUI-1
    C0006777
    Prompt
    Description

    Prompt

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1602245
    Prompt Number
    Description

    Prompt Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1602245
    UMLS CUI [1,2]
    C0237753
    Food Category
    Description

    Food Category

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0016452
    UMLS CUI [1,2]
    C0683312
    Retour au début de la page

    Similar models

    Breakfast; Ad-Lib snack total; Cotinine Test; Energy Intake Ad-Lib snack

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Study
    Item
    Study
    text
    C2603343 (UMLS CUI [1])
    Subject
    Item
    Subject
    text
    C0681850 (UMLS CUI [1])
    Collected by
    Item
    Collected by
    text
    C3244127 (UMLS CUI [1])
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Study Phase
    Item
    Study Phase
    text
    C0205390 (UMLS CUI [1,1])
    C2603343 (UMLS CUI [1,2])
    Session
    Item
    Session
    text
    C1883017 (UMLS CUI [1])
    Item Group
    Breakfast
    C2698559 (UMLS CUI-1)
    Breakfast - Physical Date
    Item
    Breakfast - Physical Date
    date
    C2698559 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Breakfast - Time
    Item
    Breakfast - Time
    time
    C2698559 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Breakfast - Day
    Item
    Breakfast - Day
    text
    C2698559 (UMLS CUI [1,1])
    C0439228 (UMLS CUI [1,2])
    Breakfast - Hour
    Item
    Breakfast - Hour
    integer
    C2698559 (UMLS CUI [1,1])
    C0439227 (UMLS CUI [1,2])
    Breakfast - Min
    Item
    Breakfast - Min
    integer
    C2698559 (UMLS CUI [1,1])
    C0439232 (UMLS CUI [1,2])
    Breakfast Start Time
    Item
    Breakfast Start Time
    time
    C1301880 (UMLS CUI [1,1])
    C2698559 (UMLS CUI [1,2])
    Breakfast Stop Time
    Item
    Breakfast Stop Time
    time
    C2698559 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0444930 (UMLS CUI [1,3])
    Item Group
    Ad-Lib snack total
    C0453863 (UMLS CUI-1)
    C0439810 (UMLS CUI-2)
    Ad-Lib snack total - Physical Date
    Item
    Ad-Lib snack total - Physical Date
    date
    C0453863 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Ad-Lib snack total - Time
    Item
    Ad-Lib snack total - Time
    time
    C0453863 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Ad-Lib snack total - Day
    Item
    Ad-Lib snack total - Day
    text
    C0453863 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0439228 (UMLS CUI [1,3])
    Ad-Lib snack total - Hour
    Item
    Ad-Lib snack total - Hour
    integer
    C0453863 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0439227 (UMLS CUI [1,3])
    Ad-Lib snack total - Min
    Item
    Ad-Lib snack total - Min
    integer
    C0453863 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0439232 (UMLS CUI [1,3])
    Ad-Lib snack total - Total High fat/High Sugar
    Item
    Ad-Lib snack total - Total High fat/High Sugar
    integer
    C0453863 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0012171 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    C0242209 (UMLS CUI [3,1])
    C0205250 (UMLS CUI [3,2])
    Ad-Lib snack total - Total High fat/Low Sugar
    Item
    Ad-Lib snack total - Total High fat/Low Sugar
    integer
    C0453863 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0012171 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    C0242209 (UMLS CUI [3,1])
    C0205251 (UMLS CUI [3,2])
    Ad-Lib snack total - Low fat/High Sugar
    Item
    Ad-Lib snack total - Low fat/High Sugar
    integer
    C0453863 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0012171 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    C0242209 (UMLS CUI [3,1])
    C0205250 (UMLS CUI [3,2])
    Ad-Lib snack total - Low fat/Low Sugar
    Item
    Ad-Lib snack total - Low fat/Low Sugar
    integer
    C0453863 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0012171 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    C0242209 (UMLS CUI [3,1])
    C0205251 (UMLS CUI [3,2])
    Item Group
    Cotinine Test
    C0202363 (UMLS CUI-1)
    Cotinine Test - Physical Date
    Item
    Cotinine Test - Physical Date
    date
    C0202363 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Cotinine Test - Time
    Item
    Cotinine Test - Time
    time
    C0202363 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Cotinine Test - Day
    Item
    Cotinine Test - Day
    text
    C0202363 (UMLS CUI [1,1])
    C0439228 (UMLS CUI [1,2])
    Cotinine Test - Hour
    Item
    Cotinine Test - Hour
    integer
    C0202363 (UMLS CUI [1,1])
    C0439227 (UMLS CUI [1,2])
    Cotinine Test - Min
    Item
    Cotinine Test - Min
    integer
    C0202363 (UMLS CUI [1,1])
    C0439232 (UMLS CUI [1,2])
    Cotinine Test - Date of Test
    Item
    Cotinine Test - Date of Test
    date
    C0202363 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Cotinine Test - Time of Test
    Item
    Cotinine Test - Time of Test
    time
    C0202363 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Cotinine Test - Result
    integer
    C0202363 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Cotinine Test - Result
    Code List
    Cotinine Test - Result
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    Item Group
    Energy intake ad-lib snack
    C0006777 (UMLS CUI-1)
    C0453863 (UMLS CUI-2)
    Energy intake ad-lib snack - Physical Date
    Item
    Energy intake ad-lib snack - Physical Date
    date
    C0006777 (UMLS CUI [1,1])
    C0453863 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Energy intake ad-lib snack - Time
    Item
    Energy intake ad-lib snack - Time
    time
    C0006777 (UMLS CUI [1,1])
    C0453863 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Energy intake ad-lib snack - Day
    Item
    Energy intake ad-lib snack - Day
    text
    C0006777 (UMLS CUI [1,1])
    C0453863 (UMLS CUI [1,2])
    C0439228 (UMLS CUI [1,3])
    Energy intake ad-lib snack - Hour
    Item
    Energy intake ad-lib snack - Hour
    integer
    C0006777 (UMLS CUI [1,1])
    C0453863 (UMLS CUI [1,2])
    C0439227 (UMLS CUI [1,3])
    Energy intake ad-lib snack - Min
    Item
    Energy intake ad-lib snack - Min
    integer
    C0006777 (UMLS CUI [1,1])
    C0453863 (UMLS CUI [1,2])
    C0439232 (UMLS CUI [1,3])
    Item Group
    Energy intake
    C0006777 (UMLS CUI-1)
    Item
    Prompt
    integer
    C1602245 (UMLS CUI [1])
    Prompt
    Code List
    Prompt
    CL Item
    Snickers Bar (1)
    CL Item
    M & M’s (2)
    CL Item
    Oreo Cookies (3)
    CL Item
    Doritos (4)
    CL Item
    Ritz Crackers with Cream Cheese (5)
    CL Item
    Shortbread (6)
    CL Item
    Crisps (7)
    CL Item
    Jelly Beans (8)
    CL Item
    Marshmallows (9)
    CL Item
    Strawberry Jelly (10)
    CL Item
    Jam Sandwich (11)
    CL Item
    Popcorn (12)
    CL Item
    Water Biscuits (13)
    CL Item
    Breadsticks (14)
    CL Item
    Pretzels (15)
    CL Item
    Choc-chip cookies  (16)
    Prompt Number
    Item
    Prompt Number
    integer
    C1602245 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item
    Food Category
    text
    C0016452 (UMLS CUI [1,1])
    C0683312 (UMLS CUI [1,2])
    Food Category
    Code List
    Food Category
    CL Item
    Low Fat/High Sugar (LFHS)
    CL Item
    High Fat/ Low Sugar (HFLS)
    CL Item
    High Fat/High Sugar (HFHS)
    CL Item
    Low Fat/Low Sugar (LFLS)
    Retour au début de la page 

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