0 Ratings
ID

40983

Description

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

Keywords

Versions (2)
  1. 6/7/20 6/7/20 -
  2. 6/7/20 6/7/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 7, 2020

DOI

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License

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

    English

    12-lead ECG V2 9-DF

    1 forms  
    1. StudyEvent: ODM
      1. 12-lead ECG V2 9-DF
    Dosing Date and Time
    Description

    Dosing Date and Time

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C0013227
    UMLS CUI-3
    C0178602
    UMLS CUI-4
    C0011008
    UMLS CUI-5
    C0040223
    Dosing date/time
    Description

    Item is not required

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Predose 1
    Description

    Predose 1

    Alias
    UMLS CUI-1
    C0439565
    Time of ECG
    Description

    Time of ECG

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Description

    PR Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    RR Interval
    Description

    Optional Item

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0489636
    msec
    QRS Axis
    Description

    Optional Item

    Data type

    integer

    Measurement units
    • degrees
    Alias
    UMLS CUI [1]
    C0429012
    degrees
    QRS Duration
    Description

    QRS Duration

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    Uncorrected QT Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTcB Interval
    Description

    QTcB Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0855331
    msec
    Result of the ECG
    Description

    Result of the ECG

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Predose 2
    Description

    Predose 2

    Alias
    UMLS CUI-1
    C0439565
    Time of ECG
    Description

    Time of ECG

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Description

    PR Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    RR Interval
    Description

    Optional Item

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0489636
    msec
    QRS Axis
    Description

    Optional Item

    Data type

    integer

    Measurement units
    • degrees
    Alias
    UMLS CUI [1]
    C0429012
    degrees
    QRS Duration
    Description

    QRS Duration

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    Uncorrected QT Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTcB Interval
    Description

    QTcB Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0855331
    msec
    Result of the ECG
    Description

    Result of the ECG

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Predose 3
    Description

    Predose 3

    Alias
    UMLS CUI-1
    C0439565
    Time of ECG
    Description

    Time of ECG

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Description

    PR Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    RR Interval
    Description

    Optional Item

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0489636
    msec
    QRS Axis
    Description

    Optional Item

    Data type

    integer

    Measurement units
    • degrees
    Alias
    UMLS CUI [1]
    C0429012
    degrees
    QRS Duration
    Description

    QRS Duration

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    Uncorrected QT Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTcB Interval
    Description

    QTcB Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0855331
    msec
    Result of the ECG
    Description

    Result of the ECG

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
    2 Hours
    Description

    2 Hours

    Alias
    UMLS CUI-1
    C0439568
    UMLS CUI-2
    C0040223
    Time of ECG
    Description

    Time of ECG

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Description

    PR Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    RR Interval
    Description

    Optional Item

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0489636
    msec
    QRS Axis
    Description

    Optional Item

    Data type

    integer

    Measurement units
    • degrees
    Alias
    UMLS CUI [1]
    C0429012
    degrees
    QRS Duration
    Description

    QRS Duration

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    Uncorrected QT Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTcB Interval
    Description

    QTcB Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0855331
    msec
    Result of the ECG
    Description

    Result of the ECG

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
    6 Hours
    Description

    6 Hours

    Alias
    UMLS CUI-1
    C0439568
    UMLS CUI-2
    C0040223
    Time of ECG
    Description

    Time of ECG

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Description

    PR Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    RR Interval
    Description

    Optional Item

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0489636
    msec
    QRS Axis
    Description

    Optional Item

    Data type

    integer

    Measurement units
    • degrees
    Alias
    UMLS CUI [1]
    C0429012
    degrees
    QRS Duration
    Description

    QRS Duration

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    Uncorrected QT Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTcB Interval
    Description

    QTcB Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0855331
    msec
    Result of the ECG
    Description

    Result of the ECG

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
    24 Hours
    Description

    24 Hours

    Alias
    UMLS CUI-1
    C0439568
    UMLS CUI-2
    C0040223
    Time of ECG
    Description

    Time of ECG

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Description

    PR Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    RR Interval
    Description

    Optional Item

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0489636
    msec
    QRS Axis
    Description

    Optional Item

    Data type

    integer

    Measurement units
    • degrees
    Alias
    UMLS CUI [1]
    C0429012
    degrees
    QRS Duration
    Description

    QRS Duration

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    Uncorrected QT Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTcB Interval
    Description

    QTcB Interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0855331
    msec
    Result of the ECG
    Description

    Result of the ECG

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
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    Similar models

    12-lead ECG V2 9-DF

    1 forms
    1. StudyEvent: ODM
      1. 12-lead ECG V2 9-DF
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Dosing Date and Time
    C0430456 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    C0178602 (UMLS CUI-3)
    C0011008 (UMLS CUI-4)
    C0040223 (UMLS CUI-5)
    Dosing date/time
    Item
    Dosing date/time
    datetime
    C0013227 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item Group
    Predose 1
    C0439565 (UMLS CUI-1)
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    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
    C0489636 (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
    C0438154 (UMLS CUI [1])
    Result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant  (2)
    CL Item
    Abnormal- clinically significant (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) (3)
    CL Item
    No result (not available) (4)
    Item Group
    Predose 2
    C0439565 (UMLS CUI-1)
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    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
    C0489636 (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
    C0438154 (UMLS CUI [1])
    Result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant  (2)
    CL Item
    Abnormal- clinically significant (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) (3)
    CL Item
    No result (not available) (4)
    Item Group
    Predose 3
    C0439565 (UMLS CUI-1)
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    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
    C0489636 (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
    C0438154 (UMLS CUI [1])
    Result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant  (2)
    CL Item
    Abnormal- clinically significant (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) (3)
    CL Item
    No result (not available) (4)
    Item Group
    2 Hours
    C0439568 (UMLS CUI-1)
    C0040223 (UMLS CUI-2)
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    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
    C0489636 (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
    C0438154 (UMLS CUI [1])
    Result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant  (2)
    CL Item
    Abnormal- clinically significant (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) (3)
    CL Item
    No result (not available) (4)
    Item Group
    6 Hours
    C0439568 (UMLS CUI-1)
    C0040223 (UMLS CUI-2)
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    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
    C0489636 (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
    C0438154 (UMLS CUI [1])
    Result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant  (2)
    CL Item
    Abnormal- clinically significant (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) (3)
    CL Item
    No result (not available) (4)
    Item Group
    24 Hours
    C0439568 (UMLS CUI-1)
    C0040223 (UMLS CUI-2)
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    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
    C0489636 (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
    C0438154 (UMLS CUI [1])
    Result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant  (2)
    CL Item
    Abnormal- clinically significant (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) (3)
    CL Item
    No result (not available) (4)
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