0 Ratings

ID

41283

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

  1. 8/10/20 8/10/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 10, 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

    Pharmacokinetics blood - (GSK1292263) V2 26-DF

    Dosing date and time
    Description

    Dosing date and time

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0178602
    UMLS CUI-3
    C0011008
    UMLS CUI-4
    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
    Description

    Predose

    Alias
    UMLS CUI-1
    C0439565
    Actual time
    Description

    Actual time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    0.5 hour
    Description

    0.5 hour

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Description

    Actual time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    1 hour
    Description

    1 hour

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Description

    Actual time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    1.5 hours
    Description

    1.5 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Description

    Actual time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    2 hours
    Description

    2 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Description

    Actual time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    3 hours
    Description

    3 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Description

    Actual time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    4 hours
    Description

    4 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Description

    Actual time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    6 hours
    Description

    6 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Description

    Actual time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    8 hours
    Description

    8 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Description

    Actual time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    10 hours
    Description

    10 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Description

    Actual time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    12 hours
    Description

    12 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual date/time
    Description

    Actual date/time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    16 hours
    Description

    16 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual date/time
    Description

    Actual date/time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    24 hours
    Description

    24 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual date/time
    Description

    Actual date/time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C1264639

    Similar models

    Pharmacokinetics blood - (GSK1292263) V2 26-DF

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Dosing date and time
    C0013227 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    C0011008 (UMLS CUI-3)
    C0040223 (UMLS CUI-4)
    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
    C0439565 (UMLS CUI-1)
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item Group
    0.5 hour
    C0439227 (UMLS CUI-1)
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item Group
    1 hour
    C0439227 (UMLS CUI-1)
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item Group
    1.5 hours
    C0439227 (UMLS CUI-1)
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item Group
    2 hours
    C0439227 (UMLS CUI-1)
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item Group
    3 hours
    C0439227 (UMLS CUI-1)
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item Group
    4 hours
    C0439227 (UMLS CUI-1)
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item Group
    6 hours
    C0439227 (UMLS CUI-1)
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item Group
    8 hours
    C0439227 (UMLS CUI-1)
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item Group
    10 hours
    C0439227 (UMLS CUI-1)
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item Group
    12 hours
    C0439227 (UMLS CUI-1)
    Actual date/time
    Item
    Actual date/time
    datetime
    C1264639 (UMLS CUI [1])
    Item Group
    16 hours
    C0439227 (UMLS CUI-1)
    Actual date/time
    Item
    Actual date/time
    datetime
    C1264639 (UMLS CUI [1])
    Item Group
    24 hours
    C0439227 (UMLS CUI-1)
    Actual date/time
    Item
    Actual date/time
    datetime
    C1264639 (UMLS CUI [1])

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