0 Ratings
ID

39866

Description

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Pharmacodynamics and Pharmacokinetics Blood form. It has to be filled in for V2b, V3, V5 and if required for logs/ repeats.

Link

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Keywords

Versions (2)
  1. 2/19/20 2/19/20 -
  2. 2/25/20 2/25/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 25, 2020

DOI

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License

Creative Commons BY-NC 4.0
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    Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

    English

    Pharmacodynamics, Pharmacokinetics Blood

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Description

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of Visit
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Visit type
    Description

    Please note for which visit you will fill in this document.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Dosing Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Dosing Time
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Pharmacodynamics/ biomarkers
    Description

    Pharmacodynamics/ biomarkers

    Alias
    UMLS CUI-1
    C0851347 (Pharmacodynamics)
    UMLS CUI-2
    C0005516 (Biological Markers)
    Time relative to dosage
    Description

    If you will fill in this form for logs/ repeats, tick "Repeat". For all other visits tick "Pre-Dose".

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Date of sample
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Time of sample
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1]
    C4064021 (specimen collection time)
    Sample ID
    Description

    Only to be filled in for logs/ repeats.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1299222 (Sample identification number)
    SNOMED
    372274003
    Pharmacokinetics Blood
    Description

    Pharmacokinetics Blood

    Alias
    UMLS CUI-1
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI-2
    C0005767 (Blood)
    SNOMED
    87612001
    LOINC
    LP71680-0
    Time relative to dosage
    Description

    For Visit 2b all timepoints have to be filled in. For Visit 3 only Pre-Dose has to be filled in. For Visit 5 only Pre-Dose, 1 Hr and 4 Hr have to be filled in. If you will fill in this form for logs/ repeats, tick "Repeat".

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Actual Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,3]
    C0005767 (Blood)
    SNOMED
    87612001
    LOINC
    LP71680-0
    Actual Time
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,3]
    C0005767 (Blood)
    SNOMED
    87612001
    LOINC
    LP71680-0
    Sample ID
    Description

    Only to be filled in for logs/ repeats.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1299222 (Sample identification number)
    SNOMED
    372274003
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    Similar models

    Pharmacodynamics, Pharmacokinetics Blood

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    V2b (1)
    CL Item
    V3 (2)
    CL Item
    V5 (3)
    CL Item
    Logs/ Repeats (4)
    Dosing Date
    Item
    Dosing Date
    date
    C0178602 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Dosing Time
    Item
    Dosing Time
    time
    C0178602 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Pharmacodynamics/ biomarkers
    C0851347 (UMLS CUI-1)
    C0005516 (UMLS CUI-2)
    Item
    Time relative to dosage
    integer
    C0439564 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Time relative to dosage
    Code List
    Time relative to dosage
    CL Item
    Pre-Dose (1)
    CL Item
    Repeat (2)
    Date of sample
    Item
    Date of sample
    date
    C1302413 (UMLS CUI [1])
    Time of sample
    Item
    Time of sample
    time
    C4064021 (UMLS CUI [1])
    Item
    Sample ID
    integer
    C1299222 (UMLS CUI [1])
    Sample ID
    Code List
    Sample ID
    CL Item
    901 (1)
    CL Item
    902 (2)
    CL Item
    903 (3)
    CL Item
    904 (4)
    CL Item
    905 (5)
    CL Item
    906 (6)
    CL Item
    907 (7)
    CL Item
    908 (8)
    CL Item
    909 (9)
    CL Item
    910 (10)
    CL Item
    911 (11)
    CL Item
    912 (12)
    CL Item
    913 (13)
    CL Item
    914 (14)
    CL Item
    915 (15)
    Item Group
    Pharmacokinetics Blood
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Time relative to dosage
    integer
    C0439564 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Time relative to dosage
    Code List
    Time relative to dosage
    CL Item
    Pre-Dose (1)
    CL Item
    30 Mins (2)
    CL Item
    1 Hr (3)
    CL Item
    2 Hr (4)
    CL Item
    4 Hr (5)
    CL Item
    8 Hr (6)
    CL Item
    Repeat (7)
    Actual Date, pharmacokinetics
    Item
    Actual Date
    date
    C0011008 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C0005767 (UMLS CUI [1,3])
    Actual Time, pharmacokinetics
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C0005767 (UMLS CUI [1,3])
    Item
    Sample ID
    integer
    C1299222 (UMLS CUI [1])
    Sample ID
    Code List
    Sample ID
    CL Item
    901 (1)
    CL Item
    902 (2)
    CL Item
    903 (3)
    CL Item
    904 (4)
    CL Item
    905 (5)
    CL Item
    906 (6)
    CL Item
    907 (7)
    CL Item
    908 (8)
    CL Item
    909 (9)
    CL Item
    910 (10)
    CL Item
    911 (11)
    CL Item
    912 (12)
    CL Item
    913 (13)
    CL Item
    914 (14)
    CL Item
    915 (15)
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