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ID

40411

Beschrijving

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

Trefwoorden

  1. 18-04-20 18-04-20 -
  2. 07-06-20 07-06-20 -
  3. 07-06-20 07-06-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

18 april 2020

DOI

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Licentie

Creative Commons BY-NC 4.0

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    40409_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

    Vital Signs Follow-up

    1. StudyEvent: ODM
      1. Vital Signs Follow-up
    Measurement 1 (of 1)
    Beschrijving

    Measurement 1 (of 1)

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI-2
    C0242485 (Measurement)
    SNOMED
    272391002
    LOINC
    LP7412-2
    UMLS CUI-3
    C1522577 (follow-up)
    Actual date/time
    Beschrijving

    Actual date/time

    Datatype

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Weight
    Beschrijving

    Weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Blood pressure systolic
    Beschrijving

    Blood pressure systolic

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Blood pressure diastolic
    Beschrijving

    Blood pressure diastolic

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Heart rate
    Beschrijving

    Heart rate

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min

    Similar models

    Vital Signs Follow-up

    1. StudyEvent: ODM
      1. Vital Signs Follow-up
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Measurement 1 (of 1)
    C0518766 (UMLS CUI-1)
    C0242485 (UMLS CUI-2)
    C1522577 (UMLS CUI-3)
    Actual date/time
    Item
    Actual date/time
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Blood pressure systolic
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood pressure diastolic
    Item
    Blood pressure diastolic
    integer
    C0871470 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])

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