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
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit type
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing Date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Dosing Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Pharmacodynamics/ biomarkers
Description

Pharmacodynamics/ biomarkers

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0005516
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
UMLS CUI [1,2]
C0178602
Date of sample
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1302413
Time of sample
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C4064021
Sample ID
Description

Only to be filled in for logs/ repeats.

Data type

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics Blood
Description

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
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
UMLS CUI [1,2]
C0178602
Actual Date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005767
Actual Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005767
Sample ID
Description

Only to be filled in for logs/ repeats.

Data type

integer

Alias
UMLS CUI [1]
C1299222
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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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