ID

41166

Description

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Versions (1)
  1. 7/3/20 7/3/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 3, 2020

DOI

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License

Creative Commons BY 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

English

Drug and Alcohol Screen; Laboratory Result Data; Urinalysis

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Drug and alcohol screen
Description

Drug and alcohol screen

Alias
UMLS CUI-1
C0202274
UMLS CUI-2
C0202304
Date and time of sample taken
Description

Date and time of sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Drug and alcohol screen
Description

Drug and alcohol screen

Alias
UMLS CUI-1
C0202274
UMLS CUI-2
C0202304
Substance
Description

Substance

Data type

integer

Alias
UMLS CUI [1]
C0439861
Drug and alcohol test finding
Description

Drug and alcohol test finding

Data type

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0202304
UMLS CUI [1,3]
C0587081
Laboratory Result Data (Haematology)
Description

Laboratory Result Data (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]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [2]
C0018941
Has the subject fasted? (Haematology)
Description

Has the subject fasted? (Haematology)

Data type

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C0018941
Laboratory Result Data (Haematology)
Description

Laboratory Result Data (Haematology)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematology test
Description

Haematology test

Data type

integer

Alias
UMLS CUI [1]
C0018941
Test Result (Haematology)
Description

Test Result (Haematology)

Data type

text

Alias
UMLS CUI [1]
C0587081
UMLS CUI [2]
C0018941
Laboratory Result Data (Clinical Chemistry)
Description

Laboratory Result Data (Clinical Chemistry)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C1274040
Date and time sample taken (Clinical Chemistry)
Description

Date and time sample taken (Clinical Chemistry)

Data type

datetime

Alias
UMLS CUI [1]
C0008000
UMLS CUI [2,1]
C0200345
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Has the subject fasted? (Clinical Chemistry)
Description

Has the subject fasted? (Clinical Chemistry)

Data type

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C0008000
Laboratory Result Data (Clinical Chemistry)
Description

Laboratory Result Data (Clinical Chemistry)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C1274040
Clinical Chemistry Test
Description

Clinical Chemistry Test

Data type

integer

Alias
UMLS CUI [1]
C0525044
Test Result (Clinical Chemistry)
Description

Test Result (Clinical Chemistry)

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0587081
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Date and time sample taken (Urinalysis)
Description

Date and time sample taken (Urinalysis)

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis (Dipstick) Test
Description

Urinalysis (Dipstick) Test

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
Urinalysis (Dipstick) Test
Description

Urinalysis (Dipstick) Test

Data type

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test Result
Description

Urinalysis (Dipstick) Test Result

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C1274040
Urinalysis (Microscopy) Test
Description

Urinalysis (Microscopy) Test

Alias
UMLS CUI-1
C0430397
Urinalysis (Microscopy) Test
Description

Urinalysis (Microscopy) Test

Data type

integer

Alias
UMLS CUI [1]
C0430397
Urinalysis (Microscopy) Test Result
Description

Urinalysis (Microscopy) Test Result

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0587081
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Similar models

Drug and Alcohol Screen; Laboratory Result Data; Urinalysis

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Drug and alcohol screen
C0202274 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
Date and time of sample taken
Item
Date and time of sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Item Group
Drug and alcohol screen
C0202274 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
Item
Substance
integer
C0439861 (UMLS CUI [1])
Substance
Code List
Substance
CL Item
Cocaine (1)
CL Item
Amphetamines (2)
CL Item
Benzodiazepines (3)
CL Item
Cannabinoids (4)
CL Item
Barbiturates (5)
CL Item
Methadone (6)
CL Item
Methamphitamine (7)
CL Item
Morphine (8)
CL Item
Cotinine (9)
CL Item
Alcohol (10)
Item
Drug and alcohol test finding
integer
C0202274 (UMLS CUI [1,1])
C0202304 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
Drug and alcohol test finding
Code List
Drug and alcohol test finding
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Laboratory Result Data (Haematology)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Date and time sample taken (Haematology)
Item
Date and time sample taken (Haematology)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
Has the subject fasted? (Haematology)
Item
Has the subject fasted? (Haematology)
boolean
C0015663 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
Item Group
Laboratory Result Data (Haematology)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematology test
integer
C0018941 (UMLS CUI [1])
Haematology test
Code List
Haematology test
CL Item
Hb (1)
(Comment:en)
CL Item
RBC (2)
(Comment:en)
CL Item
MCV (3)
(Comment:en)
CL Item
MCH (4)
(Comment:en)
CL Item
MCHC (5)
(Comment:en)
CL Item
Haematocrit (6)
(Comment:en)
CL Item
WBC (7)
(Comment:en)
CL Item
Neutrophils (8)
(Comment:en)
CL Item
Lymphocytes (9)
(Comment:en)
CL Item
Monocytes (10)
(Comment:en)
CL Item
Eosinophils (11)
CL Item
Basophils (12)
CL Item
Granulocytes (13)
CL Item
Platelets (14)
Test Result (Haematology)
Item
Test Result (Haematology)
text
C0587081 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
Item Group
Laboratory Result Data (Clinical Chemistry)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Date and time sample taken (Clinical Chemistry)
Item
Date and time sample taken (Clinical Chemistry)
datetime
C0008000 (UMLS CUI [1])
C0200345 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Has the subject fasted? (Clinical Chemistry)
Item
Has the subject fasted? (Clinical Chemistry)
boolean
C0015663 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item Group
Laboratory Result Data (Clinical Chemistry)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Item
Clinical Chemistry Test
integer
C0525044 (UMLS CUI [1])
Clinical Chemistry Test
Code List
Clinical Chemistry Test
CL Item
Urea (1)
CL Item
Creatinine (2)
CL Item
Uric acid (3)
CL Item
Total bilirubin (4)
CL Item
Total protein (5)
CL Item
Albumin (6)
CL Item
Globulin (7)
CL Item
Alkaline phosphatase (8)
CL Item
AST (9)
CL Item
ALT (10)
CL Item
Gamma GT (11)
CL Item
Phosphate (12)
CL Item
Potassium (13)
CL Item
Sodium (14)
CL Item
Calcium (15)
CL Item
Chloride (16)
CL Item
Dicarbonate (17)
CL Item
CPK (18)
CL Item
Glucose (19)
Test Result (Clinical Chemistry)
Item
Test Result (Clinical Chemistry)
text
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Date and time sample taken (Urinalysis)
Item
Date and time sample taken (Urinalysis)
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Urinalysis (Dipstick) Test
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
Item
Urinalysis (Dipstick) Test
integer
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis (Dpstick) Test
Code List
Urinalysis (Dipstick) Test
CL Item
Protein (1)
CL Item
Blood (2)
CL Item
Ketones (3)
CL Item
Glucose (4)
CL Item
Bilirubin (5)
CL Item
Urobilinogen (6)
CL Item
Leukocyte esterase (7)
CL Item
Specific gravity (8)
CL Item
Nitrites (9)
CL Item
pH (10)
Urinalysis (Dipstick) Test Result
Item
Urinalysis (Dipstick) Test Result
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item Group
Urinalysis (Microscopy) Test
C0430397 (UMLS CUI-1)
Item
Urinalysis (Microscopy) Test
integer
C0430397 (UMLS CUI [1])
Urinalysis (Microscopy) Test
Code List
Urinalysis (Microscopy) Test
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Urinalysis (Microscopy) Test Result
Item
Urinalysis (Microscopy) Test Result
text
C0430397 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
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