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ID
31985
Beschreibung
Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive
Stichworte
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Rechteinhaber
GSK group of companies
Hochgeladen am
10. Oktober 2018
DOI
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Creative Commons BY-NC 3.0
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Extension balance and metabolic disposition of vilanterol as a single oral dose 106181
Study period description
- StudyEvent: ODM
Ähnliche Modelle
Study period description
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Drug and Alcohol Screen Day-1
Item
Drug and Alcohol Screen Day-1
datetime
Physical Examination Day 1
Item
Physical Examination Day 1
date
Current physical findings - Change from baseline:
Item
Current physical findings - Change from baseline:
text
Skin
Item
Skin
boolean
Lungs
Item
Lungs
boolean
Cardiovascular
Item
Cardiovascular
boolean
Abdomen (liver and spleen)
Item
Abdomen (liver and spleen)
boolean
Item Group
Electronically transferred laboratory data Day 1
Clinical chemistry
Item
Clinical chemistry
datetime
Haematology
Item
Haematology
datetime
Urinalisys
Item
Urinalisys
datetime
Blood
Item
Blood
datetime
Blood sample number
Item
Blood sample number
text
Date
Item
Date
date
Planned relative time
Item
Planned relative time
integer
Actual time
Item
Actual time
integer
Blood pressure
Item
Blood pressure
text
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
Diastolic blood pressure
Item
Diastolic blood pressure
integer
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
text
C0039476 (UMLS CUI [1])
Start date of ECG
Item
Start date of ECG
date
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
Planned Relative Time
Item
Planned Relative Time
time
C0439564 (UMLS CUI [1])
Start Time of ECG
Item
Start Time of ECG
time
C1301880 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Invertal
Item
QTc Invertal
integer
C0860814 (UMLS CUI [1])
Method of measurement
Item
Method of measurement
text
QTcB Interval
Item
QTcB Interval
integer
QTcF Interval
Item
QTcF Interval
integer
QTc Interval unknown method of correction
Item
QTc Interval unknown method of correction
integer
Result of the ECG
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
CL Item
ECG 1 (1)
CL Item
ECG 2 (2)
CL Item
ECG 3 (3)
CL Item
ECG 4 (4)
CL Item
ECG 5 (5)
CL Item
ECG 6 (6)
CL Item
ECG 7 (7)
CL Item
ECG 8 (8)
Start date of ECG
Item
Start date of ECG
text
CL Item
pre-dose 1 (ECG 1)
CL Item
pre-dose 2 (ECG 2)
CL Item
pre-dose 3 (ECG 3)
CL Item
0.5 hrs (ECG 4)
CL Item
1 hr (ECG 5)
CL Item
2 hrs (ECG 6)
CL Item
6 hrs (ECG 7)
CL Item
12 hrs (ECG 8)
Start Time of ECG
Item
Start Time of ECG
time
Heart rate
Item
Heart rate
integer
PR Interval
Item
PR Interval
integer
QRS Duration
Item
QRS Duration
integer
QRS Duration
Item
QRS Duration
integer
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
Method of measurement
Item
Method of measurement
text
QTcB Interval
Item
QTcB Invertal
integer
QTcF Interval
Item
QTcF Invertal
integer
QTc Interval unknown method of correction
Item
QTc Interval unknown method of correction
integer
Result of the ECG
Item
Result of the ECG
integer
Date of ECG
Item
Date of ECG
date
Time of ECG
Item
Time of ECG
time
CL Item
[A 1] Sinus bradycardia (1)
CL Item
[A21] Sinus bradycardia (heart rate 40-50 beats/min) (2)
CL Item
[A22] Sinus bradycardia (heart rate 30-39 beats/min) (3)
CL Item
[A23] Sinus bradycardia (heart rate < 30 beats/min) (4)
CL Item
[A 3] Sinus pause (5)
CL Item
[A 2] Sinus tachycardia (6)
CL Item
[A 4] Ectropic supraventricular beats (7)
CL Item
[A20] Ectropic supraventricular rythm (8)
CL Item
[A17] Wandering atrial pacemaker (9)
CL Item
[A26] Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate > 100 beats/min) (10)
CL Item
[A 6] Supraventricular tachycardia (Heart rate > 100 beats/min) (11)
CL Item
[A 7] Atrial flutter (12)
CL Item
[A 8] Atrial fibrillation (13)
CL Item
[A 5] Junctional rhythm (heart rate <100 beats/min) (14)
CL Item
[A25] Junctional rhythm (15)
CL Item
[A24] Junctional tachycardia (heart rate > 100 beats/min) (16)
CL Item
[A 9] Ectopic ventricular beats (17)
CL Item
[B 3] right ventricular hypertrophy (1)
CL Item
[B 5] Intraatrial conduction delay (2)
CL Item
[B 7] Poor R wave progression (3)
CL Item
[B 9] Left atrial abnormality (4)
CL Item
[B10] Right atrial abnormality (5)
CL Item
[A12] Ventricular couplets (6)
CL Item
[A13] Bigeminy (7)
CL Item
[A28] Trigeminy (8)
CL Item
[A14] Electrical alternans (9)
CL Item
[A29] R on T phenomenon (10)
CL Item
[A18] Ventricular vebrilation (11)
CL Item
[A19] Indioventricular rhythm (heart rate < 100 bpm) (12)
CL Item
[A10] Sustained ventricular tachycardia (13)
CL Item
[A11] Non-sustained ventricular tachycardia (14)
CL Item
[A33] Sinus arrhythmia (15)
CL Item
[A33] Sinus arrhythmia (15)
CL Item
[A27] Ventricular tachycardia (16)
CL Item
[A30] Monomorphic ventricular tachycardia (17)
CL Item
[A15] Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (18)
CL Item
[A31] Polymorphic (sustained and non-sustained) ventricular tachycardia (19)
CL Item
[A16] Artificial pacemaker (20)
CL Item
[A35] Atrial premature complex (21)
CL Item
[A99]Other abnormal rhythm (22)
CL Item
[B16] Late R wave transition (23)
CL Item
[D14] Increased voltage consistent with left ventricular hypertrophy (24)
CL Item
[B99] Other morphology (25)
CL Item
[C 1] First degree AV block (PR interval > 200 msec) (1)
CL Item
[C20] Short PR interval (2)
CL Item
[C 2] Second degree AV block (Mobitz type 1) (3)
CL Item
[C 3] Second degree AV block (Mobitz type 2) (4)
CL Item
[C16] 2:1 AV block (5)
CL Item
[C 4] Third degree AV block (6)
CL Item
[C 5] Left axis deviation (QRS axis more negative than -30°) (7)
CL Item
[C 6] Right axis deviation (QRS axis more positive than +110°) (8)
CL Item
[C 7] Incomplete right bundle branch block (9)
CL Item
[C13] Incomplete left bundle branch block (10)
CL Item
[C 8] Right bundle branch block (11)
CL Item
[C 14] Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
CL Item
[D 1] Myocardial infraction, old (1)
CL Item
[D 2] Myocardial infraction, anterior (2)
CL Item
[D 3] Myocardial infraction, lateral (3)
CL Item
[D 4] Myocardial infraction, posterior (4)
CL Item
[D 5] Myocardial infraction, inferior (5)
CL Item
[D 7] Non-specific ST-T changes (1)
CL Item
[D19] J point elevation (2)
CL Item
[D 8] ST elevation (3)
CL Item
[D21] ST elevation-pericarditis (4)
CL Item
[D 9] ST depression (5)
CL Item
[D96] ST segment abnormality, not specified (6)
CL Item
[D10] U waves abnormal (7)
CL Item
[D11] T wave inversion (8)
CL Item
[D12] T wave peaked (9)
CL Item
[E99] Other abnormalities (1)
CL Item
[C15] Left posterior hemiblock (synonymous to left posterior fascicular block) (2)
CL Item
[C 9] Left bundle branch block (3)
CL Item
[C17] Bifascicular block (4)
CL Item
[C10] Non-specific intraventricular conduction delay (QRS>120msec) (5)
CL Item
[C11] Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (6)
CL Item
[C18] AV dissociation (7)
CL Item
[C28] Prolonged QT 450-500 (8)
CL Item
[C29] Prolonged QT >500 (9)
CL Item
[C30] Prolonged QTc Interval 450-500 (10)
CL Item
[C31] Prolonged QTc Interval >500 (11)
CL Item
[C99] Other conduction (12)
CL Item
[D 6] Myocardial infraction, septal (13)
CL Item
[D20] Myocardial infraction, Non-Q wave (14)
CL Item
[D08] Other myocardial infraction (15)
CL Item
[D15] T waves flat (16)
CL Item
[D16] T waves biphasic (17)
CL Item
[D18] Notched T-waves (18)
CL Item
[D13] Low QRS voltage (19)
CL Item
[D17] T-wave flattening/inversion (20)
CL Item
[D22] Juvenile T wave pattern, early repolarization (21)
CL Item
[D97] T wave abnormality, not specified (22)
CL Item
[D99] Other depolarization/repolarization (23)
Randomisation number Day 1
Item
Randomisation number Day 1
integer
CL Item
14C-GW642444 (14C-GW642444)
Date of actual dose
Item
Date of actual dose
date
Time of actual dose
Item
Time of actual dose
time
Actual dose
Item
Actual dose
integer
Units
Item
integer
Route
Item
Route
text
Formulation
Item
Formulation
text
CL Item
Yes (1)
CL Item
No (2)
If "No" record reasons
Item
If "No" record reasons
text
Blood - Day1
Item
Blood - Day1
text
CL Item
Pre-dose (1)
CL Item
0.25 hrs (2)
CL Item
0.5 hrs (3)
CL Item
0.75 hrs (4)
CL Item
1 hr (5)
CL Item
1.25 hrs (6)
CL Item
1.5 hrs (7)
CL Item
2 hrs (8)
CL Item
2.5hrs (9)
CL Item
3 hrs (10)
CL Item
3.5 hrs (11)
CL Item
4 hrs (12)
CL Item
5 hrs (13)
CL Item
6 hrs (15)
CL Item
24 hrs (16)
CL Item
48 hrs (17)
CL Item
72 hrs (18)
CL Item
96 hrs (19)
CL Item
120 hrs (20)
CL Item
144 hrs (21)
Date sample taken
Item
Date sample taken
date
Actual time
Item
Actual time
time
Blood - Metabolite samples
Item
Blood - Metabolite samples
text
CL Item
Pre-dose (1)
CL Item
0.5 hrs (2)
CL Item
1.5 hrs (3)
CL Item
3 hrs (4)
CL Item
24 hrs (5)
CL Item
unscheduled (6)
CL Item
unscheduled (7)
CL Item
unscheduled (8)
CL Item
unscheduled (9)
Date sample taken
Item
Date sample taken
date
Actual time
Item
Actual time
time
CL Item
104 (1)
CL Item
109 (2)
CL Item
114 (3)
CL Item
118 (4)
CL Item
126 (5)
Urine
Item
Urine
text
Pharmacokinetic Sampling Urine Interval Collection Data - Day 1
Item
Pharmacokinetic Sampling Urine Interval Collection Data - Day 1
text
CL Item
Pre-dose (1)
CL Item
0 hr - 24 hrs (2)
CL Item
24 hr - 48 hrs (3)
CL Item
48 hrs - 72 hrs (4)
CL Item
72 hrs - 96 hrs (5)
CL Item
96 hrs - 120 hrs (6)
CL Item
120 hrs - 144 hrs (7)
CL Item
144 hrs - 168 hrs (8)
CL Item
168 hrs - 192 hrs (9)
CL Item
192 hrs - 216 hrs (10)
CL Item
216 hrs - 240 hrs (11)
CL Item
unscheduled (12)
CL Item
unscheduled (13)
CL Item
unscheduled (14)
Start date
Item
Start date
date
Actual start time
Item
Actual start time
time
Stop date
Item
Stop date
date
Actual stop time
Item
Actual stop time
time
Toltal sample weight
Item
Toltal sample weight
float
CL Item
105 (1)
CL Item
127 (2)
CL Item
130 (3)
CL Item
133 (4)
CL Item
136 (5)
CL Item
139 (6)
CL Item
142 (7)
CL Item
145 (8)
CL Item
147 (9)
CL Item
149 (10)
CL Item
151 (11)
Faeces
Item
Faeces
text
Pharmacokintec sampling faeces interval collection data - Day1
Item
Pharmacokintec sampling faeces interval collection data - Day1
text
CL Item
Pre-dose (1)
CL Item
0 hr - 24 hrs (2)
CL Item
24 hr - 48 hrs (3)
CL Item
48 hrs - 72 hrs (4)
CL Item
72 hrs - 96 hrs (5)
CL Item
96 hrs - 120 hrs (6)
CL Item
120 hrs - 144 hrs (7)
CL Item
144 hrs - 168 hrs (8)
CL Item
168 hrs - 192 hrs (9)
CL Item
192 hrs - 216 hrs (10)
CL Item
216 hrs - 240 hrs (11)
CL Item
240 hrs - 264 hrs (12)
CL Item
264 hrs - 288 hrs (13)
CL Item
288 hrs - 312 hrs (14)
CL Item
312 hrs - 336 hrs (15)
CL Item
unscheduled (16)
Start Date
Item
Start Date
date
Actual start time
Item
Actual start time
time
Stop Date
Item
Stop Date
date
Actual stop time
Item
Actual stop time
time
Total sample weight
Item
Total sample weight
float
CL Item
106 (1)
CL Item
128 (2)
CL Item
131 (3)
CL Item
134 (4)
CL Item
137 (5)
CL Item
140 (6)
CL Item
143 (7)
CL Item
146 (8)
CL Item
148 (9)
CL Item
150 (10)
CL Item
152 (11)
CL Item
153 (12)
CL Item
154 (13)
CL Item
155 (14)
CL Item
156 (15)
Entero test - Day 1
Item
Entero test - Day 1
text
CL Item
2 (1)
CL Item
5.5 (2)
CL Item
6.5 (3)
CL Item
Insert capsule (1)
CL Item
Food stimulus (2)
CL Item
Remove string (3)
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Stop Time
Item
Stop Time
time