ID

41682

Beschreibung

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

Stichworte

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  1. 13.12.20 13.12.20 -
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GlaxoSmithKline

Hochgeladen am

13. Dezember 2020

DOI

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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

Englisch

Logs and Repeats - Pharmacokinetics Blood; Local Laboratory; Summary Holter; Holter Abnormalities

1 Formulare  
Pharmacokinetics Blood
Beschreibung

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Actual date/time
Beschreibung

Actual date/time

Datentyp

datetime

Alias
UMLS CUI [1]
C1264639
Pulmonary Function Tests
Beschreibung

Pulmonary Function Tests

Alias
UMLS CUI-1
C0024119
Date/time of test
Beschreibung

Date/time of test

Datentyp

datetime

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

FEV1 (3 readings) - 1

Datentyp

integer

Maßeinheiten
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2
Beschreibung

FEV1 (3 readings) - 2

Datentyp

integer

Maßeinheiten
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3
Beschreibung

FEV1 (3 readings) - 3

Datentyp

integer

Maßeinheiten
  • L
Alias
UMLS CUI [1]
C0748133
L
FVC (3 readings) - 1
Beschreibung

FVC (3 readings) - 1

Datentyp

integer

Maßeinheiten
  • L
Alias
UMLS CUI [1]
C1287681
L
FVC (3 readings) - 2
Beschreibung

FVC (3 readings) - 2

Datentyp

integer

Maßeinheiten
  • L
Alias
UMLS CUI [1]
C1287681
L
FVC (3 readings) - 3
Beschreibung

FVC (3 readings) - 3

Datentyp

integer

Maßeinheiten
  • L
Alias
UMLS CUI [1]
C1287681
L
Local Laboratory
Beschreibung

Local Laboratory

Alias
UMLS CUI-1
C0022885
Date and time sample taken
Beschreibung

Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Has the subject fasted?
Beschreibung

Has the subject fasted?

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
Laboratory Test - Clinical Chemistry
Beschreibung

Laboratory Test - Clinical Chemistry

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
Laboratory Test - Haematology
Beschreibung

Laboratory Test - Haematology

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0018941
Laboratory Test Result - Numeric
Beschreibung

Laboratory Test Result - Numeric

Datentyp

integer

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C2347373
Laboratory result - Character result
Beschreibung

Laboratory result - Character result

Datentyp

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C2350015
Laboratory - No result
Beschreibung

Laboratory - No result

Datentyp

integer

Alias
UMLS CUI [1]
C0587081
Summary Holter
Beschreibung

Summary Holter

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0242482
Start Date and Time of Holter
Beschreibung

Start Date and Time of Holter

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0013801
UMLS CUI [2,2]
C1301880
Stop Date and Time of Holter
Beschreibung

Stop Date and Time of Holter

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0013801
UMLS CUI [2,2]
C1522314
MInimum heart rate
Beschreibung

MInimum heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C1524031
beats/min
Maximum heart rate
Beschreibung

Maximum heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0806909
beats/min
Mean heart rate
Beschreibung

Mean heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C1881634
beats/min
Number of ventricular runs
Beschreibung

Number of ventricular runs

Datentyp

integer

Alias
UMLS CUI [1]
C2189285
Number of ventricular runs - Not done, specify reason
Beschreibung

Number of ventricular runs - Not done, specify reason

Datentyp

text

Alias
UMLS CUI [1,1]
C2189285
UMLS CUI [1,2]
C2826287
Number of ventricular runs - Not applicable
Beschreibung

Number of ventricular runs - Not applicable

Datentyp

integer

Alias
UMLS CUI [1]
C2189285
Number of supraventricular runs
Beschreibung

Number of supraventricular runs

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039240
UMLS CUI [1,2]
C0237753
Supraventricular runs - Not done, specify reason
Beschreibung

Supraventricular runs - Not done, specify reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0039240
UMLS CUI [1,2]
C2826287
Supraventricular runs - Not applicable
Beschreibung

Supraventricular runs - Not applicable

Datentyp

integer

Alias
UMLS CUI [1]
C0039240
Interpretation of Holter
Beschreibung

Interpretation of Holter

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C4086187
Holter Abnormalities
Beschreibung

Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C1704258
Start Date and Time of Holter
Beschreibung

Start Date and Time of Holter

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0013801
UMLS CUI [2,2]
C1301880
Stop Date and Time of Holter
Beschreibung

Stop Date and Time of Holter

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0013801
UMLS CUI [2,2]
C1522314
Holter Abnormalities
Beschreibung

Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C1704258
Holter abnormality
Beschreibung

Holter abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1704258
Other abnormal rhythm, specify
Beschreibung

Other abnormal rhythm, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0199556
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348235
Other morphology, specify
Beschreibung

Other morphology, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0332437
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Other conduction, specify
Beschreibung

Other conduction, specify

Datentyp

text

Alias
UMLS CUI [1]
C0340494
UMLS CUI [2]
C2348235
Other myocardial infarction, specify
Beschreibung

Other myocardial infarction, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Other depolarisation/repolrisation, specify
Beschreibung

Other depolarisation/repolrisation, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Other abnormality/ Cardiologist comments
Beschreibung

Other abnormality/ Cardiologist comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0175906
UMLS CUI [2,2]
C0947611
Holter monitoring method
Beschreibung

integer

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0871511
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Ähnliche Modelle

Logs and Repeats - Pharmacokinetics Blood; Local Laboratory; Summary Holter; Holter Abnormalities

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Pharmacokinetics Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Item Group
Pulmonary Function Tests
C0024119 (UMLS CUI-1)
Date/time of test
Item
Date/time of 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
C0022885 (UMLS CUI-1)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Has the subject fasted?
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item
Laboratory Test - Clinical Chemistry
integer
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Laboratory Test - Clinical Chemistry
Code List
Laboratory Test - Clinical Chemistry
CL Item
Albumin (1)
CL Item
Alkaline Phosphatse (2)
CL Item
ALT (3)
CL Item
AST (4)
CL Item
Calcium (5)
CL Item
Creatinine (6)
CL Item
Direct Bilirubin (7)
CL Item
GGT (8)
CL Item
Glucose (9)
CL Item
Potassium (10)
CL Item
Sodium (11)
CL Item
Total Bilirubin (12)
CL Item
Total Protein (13)
CL Item
Urea (14)
CL Item
Uric Acid (15)
Item
Laboratory Test - Haematology
integer
C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Laboratory Test - Haematology
Code List
Laboratory Test - Haematology
CL Item
Basophils (1)
CL Item
Eosinophils (2)
CL Item
Haemoglobin (3)
CL Item
Haematocrit (4)
CL Item
Lymphocytes (5)
CL Item
MCH (6)
CL Item
MCHC (7)
CL Item
MCV (8)
CL Item
Monocytes (9)
CL Item
Neutrophils (10)
CL Item
RBC (11)
CL Item
WBC (12)
Laboratory Test Result - Numeric
Item
Laboratory Test Result - Numeric
integer
C0587081 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Laboratory result - Character result
Item
Laboratory result - Character result
text
C0587081 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Laboratory - No result
integer
C0587081 (UMLS CUI [1])
Laboratory - No result
Code List
Laboratory - No result
CL Item
No result (1)
Item Group
Summary Holter
C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
MInimum heart rate
Item
MInimum heart rate
integer
C0018810 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Maximum heart rate
Item
Maximum heart rate
integer
C0018810 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Mean heart rate
Item
Mean heart rate
integer
C1881634 (UMLS CUI [1])
Number of ventricular runs
Item
Number of ventricular runs
integer
C2189285 (UMLS CUI [1])
Number of ventricular runs - Not done, specify reason
Item
Number of ventricular runs - Not done, specify reason
text
C2189285 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Item
Number of ventricular runs - Not applicable
integer
C2189285 (UMLS CUI [1])
Number of ventricular runs - Not applicable
Code List
Number of ventricular runs - Not applicable
CL Item
Not applicable (1)
Number of supraventricular runs
Item
Number of supraventricular runs
integer
C0039240 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Supraventricular runs - Not done, specify reason
Item
Supraventricular runs - Not done, specify reason
text
C0039240 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Item
Supraventricular runs - Not applicable
integer
C0039240 (UMLS CUI [1])
Supraventricular runs - Not applicable
Code List
Supraventricular runs - Not applicable
CL Item
Not applicable (1)
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C4086187 (UMLS CUI [1,2])
Interpretation of Holter
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (4)
CL Item
Unable to evaluate (8)
Item Group
Holter Abnormalities
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item Group
Holter Abnormalities
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Item
Holter abnormality
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Holter abnormality
Code List
Holter abnormality
CL Item
Electrical alternans (A21)
CL Item
R on T phenomenon (A22)
CL Item
Ventricular fibrillation (A23)
CL Item
Trigeminy (A20)
CL Item
Ventricular premature depolarisation (A17)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (A26)
CL Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A25)
CL Item
Idioventricular rhythm (<= beats/min, defined by wide QRS complex) (A24)
CL Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (A12)
CL Item
Atrial flutter (A13)
CL Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A28)
CL Item
Atrial fibrillation (A14)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A29)
CL Item
Ventricular couplets (A18)
CL Item
Bigeminy (A19)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (A10)
CL Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (A11)
CL Item
Torsade de Pointes (TdP) (A32)
CL Item
Pacemaker (A33)
CL Item
Wide QRS tachycardia (diagnosis unknown) (A27)
CL Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A30)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (A15)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A31)
CL Item
Junctional tachycardia (>100 beats/min) (A16)
CL Item
Short PR Interval (A35)
CL Item
No abnormalities (A00)
CL Item
Sinus bradycardia (50-59 beats/min) (A01)
CL Item
Sinus bradycardia (40-49 beats/min) (A02)
CL Item
Sinus bradycardia (30-39 beats/min) (A03)
CL Item
Sinus bradycardia (<30 beats/min) (A04)
CL Item
Sinus pause (A05)
CL Item
Sinus tachycardia (>100 beats/min) (A06)
CL Item
Ectopic supraventricular beats (A07)
CL Item
Ectopic supraventricular rhythm (A08)
CL Item
Wandering atrial pacemaker (A09)
CL Item
First degree AV block (PR Interval >200msec) (A34)
CL Item
Second degree AV block (Mobitz type 1) (A36)
CL Item
Second degree AV block (Mobitz type 2) (A37)
CL Item
2:1 AV block (A38)
CL Item
Third degree AV block (A39)
CL Item
Left axis deviation (QRS axis more negative thant -30 degrees) (A40)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (A41)
CL Item
Incomplete right bundle branch block (A42)
CL Item
Incomplete left bundle branch block (A43)
CL Item
Right bundle branch block (A44)
CL Item
Left anterior hemiblock (A45)
CL Item
Left posterior hemiblock (A46)
CL Item
Left bundle branch block (A47)
CL Item
Bifascicular block (A48)
CL Item
Non-specific intraventricular conduction delay (QRS >=120 msec) (A49)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-levine) (A50)
CL Item
QTc prolongation >=500 msec (A51)
CL Item
AV dissociation (A52)
CL Item
Myocardial Infarction, old (A53)
CL Item
Myocardial Infarction, non Q-wave (A54)
CL Item
Non-specific ST-T changes (A55)
CL Item
J point elevation (A56)
CL Item
ST elevation (A57)
CL Item
ST depression (A58)
CL Item
St segment abnormality (A59)
CL Item
U waves (A60)
CL Item
T wave Inversion (A61)
CL Item
T wave peaked (A62)
CL Item
T waves biphasic (A63)
CL Item
T waves flat (A64)
CL Item
Notched T-waves (A65)
CL Item
Low QRS voltage (A66)
CL Item
T wave abnormality (A67)
CL Item
Other abnormal rhythm (A94)
CL Item
Other morphology (A95)
CL Item
Other conduction (A96)
CL Item
Other myocardial infarction (A97)
CL Item
Other depolarisation/repolarisation (A98)
CL Item
Other abnormality/Cardiologist comments (A99)
Other abnormal rhythm, specify
Item
Other abnormal rhythm, specify
text
C0199556 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Other morphology, specify
Item
Other morphology, specify
text
C0332437 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other conduction, specify
Item
Other conduction, specify
text
C0340494 (UMLS CUI [1])
C2348235 (UMLS CUI [2])
Other myocardial infarction, specify
Item
Other myocardial infarction, specify
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other depolarisation/repolrisation, specify
Item
Other depolarisation/repolrisation, specify
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other abnormality/ Cardiologist comments
Item
Other abnormality/ Cardiologist comments
text
C1704258 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
Item
Holter monitoring method
integer
C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
Holter monitoring method
Code List
Holter monitoring method
CL Item
12 Lead 1000Hz  (1)
CL Item
12 Lead 180Hz  (2)
CL Item
3 Lead 180Hz  (3)
CL Item
3 Lead 512Hz (4)
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