ID

41640

Description

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (1)
  1. 11/30/20 11/30/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 30, 2020

DOI

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License

Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

English

Screening - Pulmonary Function Tests; Local Laboratory

1 forms  
Date of visit/assessment
Description

Date of visit/assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Description

Date of visit/assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Pulmonary Function Tests
Description

Pulmonary Function Tests

Alias
UMLS CUI-1
C0024119
Date/ time of pulmonary function test
Description

Date/ time of pulmonary function test

Data type

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
FEV1 (3 readings) - 1
Description

FEV1 (3 readings) - 1

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2
Description

FEV1 (3 readings) - 2

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3
Description

FEV1 (3 readings) - 3

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FVC (3 readings) - 1
Description

FVC (3 readings) - 1

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C1287681
L
FVC (3 readings) - 2
Description

FVC (3 readings) - 2

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C1287681
L
FVC (3 readings) - 3
Description

FVC (3 readings) - 3

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C1287681
L
Local Laboratory - Haematology
Description

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Date and time sample taken (Haematology)
Description

Date and time sample taken (Haematology)

Data type

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0040223
UMLS CUI [3]
C0018941
Has the subject fasted? (Haematology)
Description

Has the subject fasted? (Haematology)

Data type

boolean

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C0018941
Local Laboratory - Haematology
Description

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Test (Haematology)
Description

Test (Haematology)

Data type

integer

Alias
UMLS CUI [1]
C0018941
Numeric test result (Haematology)
Description

Numeric test result (Haematology)

Data type

float

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2347373
Character test result (Haematology)
Description

Character test result (Haematology)

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2350015
No reult (Haematology)
Description

No reult (Haematology)

Data type

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1274040
Local Laboratory - Clinical Chemistry
Description

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Date and time sample taken (Clinical Chemistry)
Description

Date and time sample taken (Clinical Chemistry)

Data type

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0040223
UMLS CUI [3]
C0008000
Has the subject fasted? (Clinical Chemistry)
Description

Has the subject fasted? (Clinical Chemistry)

Data type

boolean

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C0008000
Local Laboratory - Clinical Chemistry
Description

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Test (Clinical Chemistry)
Description

Test (Clinical Chemistry)

Data type

integer

Alias
UMLS CUI [1]
C0525044
Numeric test result (Clinical Chemistry)
Description

Numeric test result (Clinical Chemistry)

Data type

float

Alias
UMLS CUI [1,1]
C0525044
UMLS CUI [1,2]
C2347373
Character test result (Clinical Chemistry)
Description

Character test result (Clinical Chemistry)

Data type

text

Alias
UMLS CUI [1,1]
C0525044
UMLS CUI [1,2]
C2350015
No reult (Clinical Chemistry)
Description

No reult (Clinical Chemistry)

Data type

text

Alias
UMLS CUI [1,1]
C0525044
UMLS CUI [1,2]
C1274040
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Similar models

Screening - Pulmonary Function Tests; Local Laboratory

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Pulmonary Function Tests
C0024119 (UMLS CUI-1)
Date/ time of pulmonary function test
Item
Date/ time of pulmonary function test
datetime
C0024119 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
FEV1 (3 readings) - 1
Item
FEV1 (3 readings) - 1
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 2
Item
FEV1 (3 readings) - 2
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 3
Item
FEV1 (3 readings) - 3
integer
C0748133 (UMLS CUI [1])
FVC (3 readings) - 1
Item
FVC (3 readings) - 1
integer
C1287681 (UMLS CUI [1])
FVC (3 readings) - 2
Item
FVC (3 readings) - 2
integer
C1287681 (UMLS CUI [1])
FVC (3 readings) - 3
Item
FVC (3 readings) - 3
integer
C1287681 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Date and time sample taken (Haematology)
Item
Date and time sample taken (Haematology)
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0018941 (UMLS CUI [3])
Has the subject fasted? (Haematology)
Item
Has the subject fasted? (Haematology)
boolean
C0015663 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Test (Haematology)
integer
C0018941 (UMLS CUI [1])
Test (Haematology)
Code List
Test (Haematology)
CL Item
WBC Absolute (1)
CL Item
RBC (2)
CL Item
Haemoglobin (3)
CL Item
Haematocrit (4)
CL Item
Neutrophils (5)
CL Item
Lymphocytes (6)
CL Item
Monocytes (7)
CL Item
Eosinophils (8)
CL Item
Basophils (9)
CL Item
MCV (10)
CL Item
MCH (11)
CL Item
MCHC (12)
Numeric test result (Haematology)
Item
Numeric test result (Haematology)
float
C0474523 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Character test result (Haematology)
Item
Character test result (Haematology)
text
C0474523 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
No reult (Haematology)
integer
C0474523 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
No reult (Haematology)
Code List
No reult (Haematology)
CL Item
No result (1)
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Date and time sample taken (Clinical Chemistry)
Item
Date and time sample taken (Clinical Chemistry)
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0008000 (UMLS CUI [3])
Has the subject fasted? (Clinical Chemistry)
Item
Has the subject fasted? (Clinical Chemistry)
boolean
C0015663 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Test (Clinical Chemistry)
integer
C0525044 (UMLS CUI [1])
Test (Clinical Chemistry)
Code List
Test (Clinical Chemistry)
CL Item
ALT (1)
CL Item
AST (2)
CL Item
Total Bilirubin (3)
CL Item
Direct Bilirubin (4)
CL Item
Glucose Fasting (5)
CL Item
GGT (6)
CL Item
Total Protein (7)
CL Item
Albumin (8)
CL Item
Potassium (9)
CL Item
Sodium (10)
CL Item
Calcium (11)
CL Item
Urea (12)
CL Item
Creatinine (13)
CL Item
Uric Acid (14)
CL Item
Alkaline Phosphatase (15)
Numeric test result (Clinical Chemistry)
Item
Numeric test result (Clinical Chemistry)
float
C0525044 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Character test result (Clinical Chemistry)
Item
Character test result (Clinical Chemistry)
text
C0525044 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
No reult (Clinical Chemistry)
Item
No reult (Clinical Chemistry)
text
C0525044 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
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