0 Evaluaciones
ID

30854

Descripción

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

Palabras clave

Versiones (1)
  1. 27/6/18 27/6/18 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

27 de junio de 2018

DOI

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Licencia

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

    Inglés

    Pharmacodynamics and -kinetics (Sessions 1 and 2)

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Descripción

    Subject Identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit Type
    Descripción

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

    Tipo de datos

    text

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

    Pharmacodynamics - Blood (Biomarker)

    Alias
    UMLS CUI-1
    C0851347 (Pharmacodynamics)
    UMLS CUI-2
    C0005516 (Biological Markers)
    UMLS CUI-3
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    Planned Relative Time
    Descripción

    Time relative to dosing

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,3]
    C0851347 (Pharmacodynamics)
    Date sample taken
    Descripción

    Date sample taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    UMLS CUI [1,2]
    C0851347 (Pharmacodynamics)
    Actual Time sample taken
    Descripción

    Time sample taken

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    UMLS CUI [1,3]
    C0851347 (Pharmacodynamics)
    Sample Number
    Descripción

    Sample Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1299222 (Sample identification number)
    SNOMED
    372274003
    UMLS CUI [1,2]
    C0851347 (Pharmacodynamics)
    Pharmacokinetics - Blood
    Descripción

    Pharmacokinetics - Blood

    Alias
    UMLS CUI-1
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI-2
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    Planned relative Time and Sample Number
    Descripción

    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)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,3]
    C0031328 (Pharmacokinetic aspects)
    Date sample Taken
    Descripción

    Date sample Taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    UMLS CUI [1,2]
    C0201734 (Pharmacokinetic study)
    SNOMED
    48684007
    Actual Time
    Descripción

    Actual Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,3]
    C0201734 (Pharmacokinetic study)
    SNOMED
    48684007
    Was sample missed or lost?
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3845781 (Lost sample)
    LOINC
    LA7348-1
    UMLS CUI [2,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [2,2]
    C1705492 (Missing)
    LOINC
    LA14698-7
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    Similar models

    Pharmacodynamics and -kinetics (Sessions 1 and 2)

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Visit
    Code List
    Subject Identifier
    Item
    Visit Type
    text
    C0545082 (UMLS CUI [1])
    Visit
    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])
    Relative Time
    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])
    Planned relative Time
    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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