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ID

40949

Beschrijving

The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

Trefwoorden

  1. 23-04-20 23-04-20 -
  2. 07-06-20 07-06-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

7 juni 2020

DOI

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Licentie

Creative Commons BY-NC 4.0

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    A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin

    12-lead ECG - Repeating Form, Logs/Repeats 7-RF-DF

    12-lead ECG
    Beschrijving

    12-lead ECG

    Alias
    UMLS CUI-1
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    Date and time of ECG
    Beschrijving

    Date and time of ECG

    Datatype

    datetime

    Alias
    UMLS CUI [1]
    C2826846 (Electrocardiogram Collection Date Time)
    Heart Rate
    Beschrijving

    Heart Rate

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    PR Interval
    Beschrijving

    PR Interval

    Datatype

    float

    Maateenheden
    • msec
    Alias
    UMLS CUI [1]
    C0429087 (Electrocardiogram: P-R interval)
    SNOMED
    365411005
    msec
    RR Interval
    Beschrijving

    RR Interval

    Datatype

    float

    Maateenheden
    • msec
    Alias
    UMLS CUI [1]
    C0429087 (Electrocardiogram: P-R interval)
    SNOMED
    365411005
    msec
    QRS Axis
    Beschrijving

    QRS Axis

    Datatype

    integer

    Maateenheden
    • degrees
    Alias
    UMLS CUI [1]
    C0429012 (QRS Axis (observable entity))
    SNOMED
    251196003
    degrees
    QRS Duration
    Beschrijving

    QRS Duration

    Datatype

    float

    Maateenheden
    • msec
    Alias
    UMLS CUI [1]
    C0429025 (QRS complex duration (observable entity))
    SNOMED
    251208001
    LOINC
    LP31031-5
    msec
    Uncorrected QT Interval
    Beschrijving

    Uncorrected QT Interval

    Datatype

    float

    Maateenheden
    • msec
    Alias
    UMLS CUI [1]
    C1287082 (QT interval - finding)
    SNOMED
    365417009
    msec
    QTcB Interval
    Beschrijving

    QTcB Interval

    Datatype

    float

    Maateenheden
    • msec
    Alias
    UMLS CUI [1]
    C0855331 (Electrocardiogram QT corrected interval)
    msec
    Result of the ECG
    Beschrijving

    If answer is "abnormal": complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE

    Datatype

    integer

    Similar models

    12-lead ECG - Repeating Form, Logs/Repeats 7-RF-DF

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    12-lead ECG
    C0430456 (UMLS CUI-1)
    Date and time of ECG
    Item
    Date and time of ECG
    datetime
    C2826846 (UMLS CUI [1])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    PR Interval
    Item
    PR Interval
    float
    C0429087 (UMLS CUI [1])
    RR Interval
    Item
    RR Interval
    float
    C0429087 (UMLS CUI [1])
    QRS Axis
    Item
    QRS Axis
    integer
    C0429012 (UMLS CUI [1])
    QRS Duration
    Item
    QRS Duration
    float
    C0429025 (UMLS CUI [1])
    Uncorrected QT Interval
    Item
    Uncorrected QT Interval
    float
    C1287082 (UMLS CUI [1])
    QTcB Interval
    Item
    QTcB Interval
    float
    C0855331 (UMLS CUI [1])
    Item
    Result of the ECG
    integer
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    C0522054 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Abnormal - not clinically significant (2)
    C0522055 (UMLS CUI-1)
    C2826632 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Abnormal - clinically significant (3)
    C0522055 (UMLS CUI-1)
    C2826632 (UMLS CUI-2)
    (Comment:en)
    CL Item
    No result (not available) (4)
    C1706613 (UMLS CUI-1)
    (Comment:en)

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