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ID

40944

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 Mellitus 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. 4/21/20 4/21/20 -
  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

    Logs and repeats Logs/Repeats 1

    1 forms  
    Date of visit/assessment
    Description

    Date of visit/assessment

    Alias
    UMLS CUI-1
    C1320303
    UMLS CUI-2
    C2985720
    Date of visit/assessment
    Description

    Date is the start of the study for this subject

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Adverse event/concomitant medication/repeat assessment check questions
    Description

    Adverse event/concomitant medication/repeat assessment check questions

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C2347852
    UMLS CUI-3
    C0205341
    UMLS CUI-4
    C0220825
    Were any concomitant medications taken by the subject during the study?
    Description

    concomitant medications

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0681850
    UMLS CUI [1,4]
    C0347984
    UMLS CUI [1,5]
    C0008972
    Did the subject experience any non-serious adverse events during the study?
    Description

    non-serious adverse events

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0681850
    UMLS CUI [1,3]
    C0347984
    UMLS CUI [1,4]
    C0008972
    Did the subject experience any serious adverse events during the study?
    Description

    serious adverse events

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0681850
    UMLS CUI [1,3]
    C0347984
    UMLS CUI [1,4]
    C0008972
    Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
    Description

    abnormal ECG measurements

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0681850
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008972
    UMLS CUI [1,4]
    C1832603
    UMLS CUI [1,5]
    C2985739
    Were any repeat haematology, clinical chemistry or urinalysis samples taken?
    Description

    repeat haematology, clinical chemistry or urinalysis samples

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0205341
    UMLS CUI [2,1]
    C0018941
    UMLS CUI [2,2]
    C0200345
    UMLS CUI [2,3]
    C0205341
    UMLS CUI [3,1]
    C0042014
    UMLS CUI [3,2]
    C0200345
    UMLS CUI [3,3]
    C0205341
    Were any repeat ECGs performed?
    Description

    repeat ECGs

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0205341
    Were any repeat vital signs recorded?
    Description

    repeat vital signs

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0205341
    Were any repeat PK blood samples taken?
    Description

    PK: pharmacokinetic

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0031327
    UMLS CUI [1,3]
    C0205341
    Were any repeat PD samples taken?
    Description

    PD: Pharmacodynamic

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0205341
    UMLS CUI [1,2]
    C0851347
    UMLS CUI [1,3]
    C0200345
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    Similar models

    Logs and repeats Logs/Repeats 1

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Date of visit/assessment
    C1320303 (UMLS CUI-1)
    C2985720 (UMLS CUI-2)
    Date of visit/assessment
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Adverse event/concomitant medication/repeat assessment check questions
    C0877248 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    C0205341 (UMLS CUI-3)
    C0220825 (UMLS CUI-4)
    Item
    Were any concomitant medications taken by the subject during the study?
    integer
    C2347852 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0681850 (UMLS CUI [1,3])
    C0347984 (UMLS CUI [1,4])
    C0008972 (UMLS CUI [1,5])
    concomitant medications
    Code List
    Were any concomitant medications taken by the subject during the study?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Did the subject experience any non-serious adverse events during the study?
    integer
    C1518404 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    C0347984 (UMLS CUI [1,3])
    C0008972 (UMLS CUI [1,4])
    non-serious adverse events
    Code List
    Did the subject experience any non-serious adverse events during the study?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Did the subject experience any serious adverse events during the study?
    integer
    C1519255 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    C0347984 (UMLS CUI [1,3])
    C0008972 (UMLS CUI [1,4])
    serious adverse events
    Code List
    Did the subject experience any serious adverse events during the study?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
    integer
    C0681850 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008972 (UMLS CUI [1,3])
    C1832603 (UMLS CUI [1,4])
    C2985739 (UMLS CUI [1,5])
    abnormal ECG measurements
    Code List
    Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Were any repeat haematology, clinical chemistry or urinalysis samples taken?
    integer
    C0008000 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0205341 (UMLS CUI [1,3])
    C0018941 (UMLS CUI [2,1])
    C0200345 (UMLS CUI [2,2])
    C0205341 (UMLS CUI [2,3])
    C0042014 (UMLS CUI [3,1])
    C0200345 (UMLS CUI [3,2])
    C0205341 (UMLS CUI [3,3])
    repeat haematology, clinical chemistry or urinalysis samples
    Code List
    Were any repeat haematology, clinical chemistry or urinalysis samples taken?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Were any repeat ECGs performed?
    integer
    C0013798 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    repeat ECGs
    Code List
    Were any repeat ECGs performed?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Were any repeat vital signs recorded?
    integer
    C0518766 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    concomitant medications
    Code List
    Were any repeat vital signs recorded?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Were any repeat PK blood samples taken?
    integer
    C1277698 (UMLS CUI [1,1])
    C0031327 (UMLS CUI [1,2])
    C0205341 (UMLS CUI [1,3])
    concomitant medications
    Code List
    Were any repeat PK blood samples taken?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Were any repeat PD samples taken?
    integer
    C0205341 (UMLS CUI [1,1])
    C0851347 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    concomitant medications
    Code List
    Were any repeat PD samples taken?
    CL Item
    Yes (1)
    CL Item
    No (2)
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