0 Ratings

ID

30854

Description

This ODM file contains Collection Information on Pharmacodynamics and Pharmacokinetics. To be filled at Sessions 1 and 2 (Day 1, different timepoints). Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Link

https://clinicaltrials.gov/ct2/show/NCT01039454

Keywords

  1. 6/27/18 6/27/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

June 27, 2018

DOI

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License

Creative Commons BY-NC 3.0

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    Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

    Pharmacodynamics and -kinetics (Sessions 1 and 2)

    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Type
    Description

    Form needs to be filled out on each attended visit mentioned below.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082
    Pharmacodynamics - Blood (Biomarker)
    Description

    Pharmacodynamics - Blood (Biomarker)

    Alias
    UMLS CUI-1
    C0851347
    UMLS CUI-2
    C0005516
    UMLS CUI-3
    C0005834
    Planned Relative Time
    Description

    Time relative to dosing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0851347
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0851347
    Actual Time sample taken
    Description

    Time sample taken

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0851347
    Sample Number
    Description

    Sample Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1299222
    UMLS CUI [1,2]
    C0851347
    Pharmacokinetics - Blood
    Description

    Pharmacokinetics - Blood

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005834
    Planned relative Time and Sample Number
    Description

    Time relative to dosing Session 1: Sample Numbers with 1 in front (Unscheduled with 1 last) Session 2: Sample Numbers with 2 in front (unscheduled with 2 last)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0031328
    Date sample Taken
    Description

    Date sample Taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0201734
    Actual Time
    Description

    Actual Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0201734
    Was sample missed or lost?
    Description

    (Originally: If sample is missed or lost, write "NA" in the Date Sample Taken column. )

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3845781
    UMLS CUI [2,1]
    C0005834
    UMLS CUI [2,2]
    C1705492

    Similar models

    Pharmacodynamics and -kinetics (Sessions 1 and 2)

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Code List
    Subject Identifier
    Item
    Visit Type
    text
    C0545082 (UMLS CUI [1])
    Code List
    Visit Type
    CL Item
    Session 1 (Session 1)
    CL Item
    Session 2 (Session 2)
    Item Group
    Pharmacodynamics - Blood (Biomarker)
    C0851347 (UMLS CUI-1)
    C0005516 (UMLS CUI-2)
    C0005834 (UMLS CUI-3)
    Item
    Planned Relative Time
    text
    C0439564 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0851347 (UMLS CUI [1,3])
    Code List
    Planned Relative Time
    CL Item
    Pre-dose (Pre-dose)
    CL Item
    2 hrs (2 hrs)
    CL Item
    48 hrs (48 hrs)
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1,1])
    C0851347 (UMLS CUI [1,2])
    Time sample taken
    Item
    Actual Time sample taken
    text
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0851347 (UMLS CUI [1,3])
    Sample Number
    Item
    Sample Number
    text
    C1299222 (UMLS CUI [1,1])
    C0851347 (UMLS CUI [1,2])
    Item Group
    Pharmacokinetics - Blood
    C0031328 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    Item
    Planned relative Time and Sample Number
    text
    C0439564 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0031328 (UMLS CUI [1,3])
    Code List
    Planned relative Time and Sample Number
    CL Item
    Pre-dose (101)
    CL Item
    0.5 hrs (102)
    CL Item
    1 hrs (103)
    CL Item
    1.5 hrs (104)
    CL Item
    3 hrs (pre-scan) (105)
    CL Item
    4 hrs (post-scan) (106)
    CL Item
    5 hrs (107)
    CL Item
    6 hrs (108)
    CL Item
    12 hrs (109)
    CL Item
    24 hrs (110)
    CL Item
    48 hrs (111)
    CL Item
    72 hrs (112)
    CL Item
    Unscheduled (901)
    CL Item
    Pre-dose (201)
    CL Item
    0.5 hrs (202)
    CL Item
    1 hrs (203)
    CL Item
    1.5 hrs (204)
    CL Item
    3 hrs (pre-scan) (205)
    CL Item
    4 hrs (post-scan) (206)
    CL Item
    5 hrs (207)
    CL Item
    6 hrs (208)
    CL Item
    12 hrs (209)
    CL Item
    24 hrs (210)
    CL Item
    48 hrs (211)
    CL Item
    72 hrs (212)
    CL Item
    Unscheduled (902)
    Date sample Taken
    Item
    Date sample Taken
    date
    C1302413 (UMLS CUI [1,1])
    C0201734 (UMLS CUI [1,2])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0201734 (UMLS CUI [1,3])
    Sample missed or lost
    Item
    Was sample missed or lost?
    boolean
    C3845781 (UMLS CUI [1])
    C0005834 (UMLS CUI [2,1])
    C1705492 (UMLS CUI [2,2])

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