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ID

41283

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

  1. 2020-08-10 2020-08-10 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

10 augusti 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

    Pharmacokinetics blood - (GSK1292263) V2 26-DF

    Dosing date and time
    Beskrivning

    Dosing date and time

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

    Item is not required

    Datatyp

    datetime

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

    Predose

    Alias
    UMLS CUI-1
    C0439565
    Actual time
    Beskrivning

    Actual time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    0.5 hour
    Beskrivning

    0.5 hour

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Beskrivning

    Actual time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    1 hour
    Beskrivning

    1 hour

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Beskrivning

    Actual time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    1.5 hours
    Beskrivning

    1.5 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Beskrivning

    Actual time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    2 hours
    Beskrivning

    2 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Beskrivning

    Actual time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    3 hours
    Beskrivning

    3 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Beskrivning

    Actual time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    4 hours
    Beskrivning

    4 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Beskrivning

    Actual time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    6 hours
    Beskrivning

    6 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Beskrivning

    Actual time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    8 hours
    Beskrivning

    8 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Beskrivning

    Actual time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    10 hours
    Beskrivning

    10 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual time
    Beskrivning

    Actual time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    12 hours
    Beskrivning

    12 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual date/time
    Beskrivning

    Actual date/time

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    16 hours
    Beskrivning

    16 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual date/time
    Beskrivning

    Actual date/time

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    24 hours
    Beskrivning

    24 hours

    Alias
    UMLS CUI-1
    C0439227
    Actual date/time
    Beskrivning

    Actual date/time

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C1264639

    Similar models

    Pharmacokinetics blood - (GSK1292263) V2 26-DF

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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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