0 Bedömningar
ID

40949

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2020-04-23 2020-04-23 -
  2. 2020-06-07 2020-06-07 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

7 juni 2020

DOI

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Licens

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

    Engelsk

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

    1 Formulär  
    12-lead ECG
    Beskrivning

    12-lead ECG

    Alias
    UMLS CUI-1
    C0430456
    Date and time of ECG
    Beskrivning

    Date and time of ECG

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    Heart Rate
    Beskrivning

    Heart Rate

    Datatyp

    integer

    Måttenheter
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Beskrivning

    PR Interval

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    RR Interval
    Beskrivning

    RR Interval

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS Axis
    Beskrivning

    QRS Axis

    Datatyp

    integer

    Måttenheter
    • degrees
    Alias
    UMLS CUI [1]
    C0429012
    degrees
    QRS Duration
    Beskrivning

    QRS Duration

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Beskrivning

    Uncorrected QT Interval

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTcB Interval
    Beskrivning

    QTcB Interval

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C0855331
    msec
    Result of the ECG
    Beskrivning

    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

    Datatyp

    integer

    Tillbaka till toppen

    Similar models

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

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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
    ECG results
    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)
    Tillbaka till toppen 

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