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ID
31990
Description
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
Keywords
Versions (6)
- 10/9/18 10/9/18 -
- 10/10/18 10/10/18 -
- 10/10/18 10/10/18 -
- 10/10/18 10/10/18 -
- 12/5/18 12/5/18 -
- 9/17/21 9/17/21 -
Copyright Holder
GSK group of companies
Uploaded on
October 10, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181
Similar models
Screening visit
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Date of birth
Item
Date of birth
date
CL Item
male (1)
CL Item
female (2)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
CL Item
Record details of the subject's ongoing concomitant medications in the appropriate Concomitant Medications section. (Record details of the subject's ongoing concomitant medications in the appropriate Concomitant Medications section.)
Height
Item
Height
integer
Weight
Item
Weight
float
Body mass index
Item
Body mass index
integer
CL Item
1. (1)
CL Item
2. (2)
CL Item
3. (3)
CL Item
screening (1)
CL Item
unscheduled (2)
CL Item
unscheduled (3)
Actual Time
Item
Actual Time
text
Blood Pressure
Item
text
Heart Rate
Item
Heart Rate
text
Temperature Oral
Item
Temperature Oral
float
Item Group
12-lead ECG
C0430456 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
CL Item
ECG one (1)
CL Item
ECG two (2)
CL Item
ECG three (3)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Planned Relative Time ECG
Item
Planned Relative Time ECG
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C2189285 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Method of measurement
Item
Method of measurement
integer
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
If machine, QTcB interval
Item
If machine, QTcB interval
integer
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
If machine, QTcF interval
Item
If machine, QTcF interval
integer
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
If machine, QTc interval unknown method of correction
Item
If machine, QTc interval unknown method of correction
integer
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
CL Item
Complete additional ECG abnormalities pages if clinically significant abnormalities are present. (Complete additional ECG abnormalities pages if clinically significant abnormalities are present.)
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
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
[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
[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)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
CL Item
Record the dates and times recorded by the Holter monitoring equipment (Record the dates and times recorded by the Holter monitoring equipment)
Start date of Holter
Item
Start date of Holter
date
Start time of Holter
Item
Start time of Holter
time
Stop time of Holter
Item
Stop time of Holter
time
CL Item
[1] Normal (1)
CL Item
[2] Abnormal - Not clinically significant (2)
CL Item
[3] Abnormal - Clinically significant (3)
CL Item
[4] No result (4)
CL Item
[8] Unable to evaluate (5)
CL Item
[1] 12 Lead 1000Hz (1)
CL Item
[2] 12 Lead 180 Hz (2)
CL Item
[3] 3 Lead 180 Hz (3)
CL Item
[4] Telemetry (4)
CL Item
[5] 5 Lead 512Hz (5)
CL Item
[6] 4 Lead 0.05-40 Hz (6)
CL Item
[7] 6 Lead 0.05-40 Hz (7)
CL Item
[8] 7 Lead 0.05-100 Hz-3dB (8)
CL Item
[9] 7 Lead 3 channel 133 Hz (9)
CL Item
[10] 2 lead 200 Hz (10)
CL Item
[OT] Other (11)
CL Item
[A01] Sinus bradycardia (50-59 bpm) (1)
CL Item
[A02] Sinus bradycardia (40-49 bpm) (2)
CL Item
[A03] Sinus bradycardia (30-39 bpm) (3)
CL Item
[A04] Sinus bradycardia (<30 bpm) (4)
CL Item
[A05] Sinus pause (5)
CL Item
[A06] Sinus tachycardia (6)
CL Item
[A07] Ectopic supraventricular beats (7)
CL Item
[A08] Ectopic supraventricular rhythm (8)
CL Item
[A09] Wandering atrial pacemaker (9)
CL Item
[A10] Multifocal atrial tachycardia (wandering atrial pacemaker w/rate>100 bpm) (10)
CL Item
[A11] Non-sustained supraventricular tachycardia (>100 bpm. >30 beats) (11)
CL Item
[A12] Sustained supraventricular tachycardia (>100 bpm. >30 beats) (12)
CL Item
[A13] Atrial flutter (13)
CL Item
[A14] Atrial fibrillation (14)
CL Item
[A15] Junctional rhythm (<=100 bpm, defined by narrow QRS complexes) (15)
CL Item
[A16] Junctional tachycardia (heart rate > 100 bpm) (16)
CL Item
[A17] Ventricular premature depolarisation (17)
CL Item
[A18] Ventricular couplets (18)
CL Item
[A19] Bigeminy (19)
CL Item
[A20] Trigeminy (20)
CL Item
[A21] Electrical alternans (21)
CL Item
[A22] R on T phenomenon (22)
CL Item
[A23] Ventricular febrillation (23)
CL Item
[A24] Idioventricular rhathm (<=100 bpm, defined by wide QRS complexes) (24)
CL Item
[A25] Non-sustained ventricular tachycardia (>100 bpm, 3-30 beats) (25)
CL Item
[A26] Sustained ventricular tachycardia (>100 bpm, >30 beats) (26)
CL Item
[A27] Wide QRS Tachycardia (diagnosis unknown) (27)
CL Item
[A28] Monomorphic non-sustained ventricular tachycardia (>100 bpm, 3-30 beats) (28)
CL Item
[A29] Monomorphic non-sustained ventricular tachycardia (>100 bpm, >30 beats) (29)
CL Item
[A30] Polymorphic non-sustained ventricular tachycardia (>100 bpm, 3-30 bpm) (30)
CL Item
[A31] Polymorphic non-sustained ventricular tachycardia (>100 bpm, >30 bpm) (31)
CL Item
[A32] Torsade de Pointes (TdP) (32)
CL Item
[A33] Pacemaker (33)
CL Item
[A34] First degree AV block (PR interval >200msec) (34)
CL Item
[A35] Short PR Interval (35)
CL Item
[A36] Second degree AV block (Mobitz type 1) (36)
CL Item
[A37] Second degree AV block (Mobitz type 2) (37)
CL Item
[A38] 2:1 AV block (38)
CL Item
[A39] Third degree AV block (39)
CL Item
[A40] Left axis deviation (QRS axis more negative than -30 degrees) (40)
CL Item
[A41] Right axis deviation (QRS axis more positive than +110 degrees) (41)
CL Item
[A42] Incomplete right bundle branch block (42)
CL Item
[A43] Incomplete left bundle branch block (43)
CL Item
[A44] Right bundle branch block (44)
CL Item
[A45] Left anterior hemiblock (45)
CL Item
[A46] Left posterior hemiblock (46)
CL Item
[A47] Left bundle branch block (47)
CL Item
[A48] Bifascicular block (48)
CL Item
[A49] Non-specific intraventricular conduction delay (QRS>=120 msec) (49)
CL Item
[A50] Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine) (50)
CL Item
[A51] QTc prolongation >=500 msec (51)
CL Item
[A52] AV dissociation (52)
CL Item
[A53] Myocardial infraction, old (53)
CL Item
[A54] Myocardial infraction, non Q-wave (54)
CL Item
[A55] Non-specific ST-T changes (55)
CL Item
[A56] J point elevation (56)
CL Item
[A57] ST elevation (57)
CL Item
[A58] ST depression (58)
CL Item
[A59] ST segment abnormality (59)
CL Item
[A60] U waves (60)
CL Item
[A61] T wave inversion (61)
CL Item
[A62] T wave peaked (62)
CL Item
[A63] T waves byphasic (63)
CL Item
[A64] T waves flat (64)
CL Item
[A65] Notched T-waves (65)
CL Item
[A66] Low QRS voltage (66)
CL Item
[A67] T wave abnormality (67)
CL Item
[A94] Other abnormal rhythm (68)
CL Item
[A95] Other morphology (69)
CL Item
___________________________________________ (___________________________________________)
CL Item
[A96] Other conduction (70)
CL Item
___________________________________________ (___________________________________________)
CL Item
[A97] Other myocardial infraction (71)
CL Item
___________________________________________ (___________________________________________)
CL Item
[A98] Other depolarisation/repolarisation (72)
CL Item
___________________________________________ (___________________________________________)
CL Item
[A99] Other abnormality/Cardiologist comments (73)
CL Item
___________________________________________ (___________________________________________)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
Current
Item
Current
boolean
Past
Item
Past
boolean
Date of Assessment
Item
Date of Assessment
date
Format
Item
Format
text
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Never smoked (1)
CL Item
Former smoker (2)
If former smoker
Item
If former smoker
date
CL Item
Number of pack years? (Number of pack years?)
Serology - HIV Screen
Item
Serology - HIV Screen
date
CL Item
Yes (1)
CL Item
No (2)
if Yes, do the following
Item
if Yes, do the following
float
Drug and Alcohol Screen
Item
Drug and Alcohol Screen
datetime
Clinical chemistry
Item
Clinical chemistry
datetime
Haematology
Item
Haematology
datetime
Urinalysis
Item
Urinalysis
datetime
Blood sample
Item
Blood sample
datetime
CL Item
[Y] Yes (1)
CL Item
[N] No (2)
CL Item
Healthy male aged between 30 and 55 years inclusive, at the time of signing the informed consent. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population, which are deemed to be clinically relevant, should always be excluded from enrollment. (1)
CL Item
Body Mass Index (BMI) within the range 18.5-29.0 kg/m2 (inclusive). (2)
CL Item
Subjects who are current non-smokers, who have not used any tobacco products in the 12 month period preceding the screening visit, and have a pack history of <= 5 pack years [number of pack years = (number of cigarettes per day/20)x number of years smoked]. (3)
CL Item
AST, ALT, alkaline phosphatase and bilirubin < = 1.5xULN (isolated bilirubin>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). (4)
CL Item
No significant abnormality on 12-lead ECG at screening. Selected specific ECG findings that are considered to be significant and will exclude the subject from study participation include, but are not limited to, the following: (5)
CL Item
110 bpm (- Sinus tachycardia >)
CL Item
- Multifocal atrial tachycadria (wandering atrial pacemaker with rate >100 bpm) (- Multifocal atrial tachycadria (wandering atrial pacemaker with rate >100 bpm))
CL Item
- PR interval >240 msec (- PR interval >240 msec)
CL Item
- Evidence of Mobitz II second degree or third degree atroventricular (AV) block (- Evidence of Mobitz II second degree or third degree atroventricular (AV) block)
CL Item
- Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm with 10mm/mV setting)] or 25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads. Note: prior evidence (i.e., ECG obtained at least 12 month prior) of pathological Q waves that are unchanged are not exclusionary. (- Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm with 10mm/mV setting)] or 25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads. Note: prior evidence (i.e., ECG obtained at least 12 month prior) of pathological Q waves that are unchanged are not exclusionary.)
CL Item
- Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. (- Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes.)
CL Item
450 msec or uncorrected QT>600 msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave). Note: QTcF>= 450 msec or uncorrected QT>600 msec should be confirmed by three readings at least 5 minutes apart (- QTcF >)
CL Item
- ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities (- ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities)
CL Item
- Right or left complete bundle branch block (- Right or left complete bundle branch block)
CL Item
- Clinically significant conduction abnormalities (e.g., atrial fibrilation with rapid ventricular response, ventricular tachycardia (- Clinically significant conduction abnormalities (e.g., atrial fibrilation with rapid ventricular response, ventricular tachycardia)
CL Item
No significant abnormality on the Holter ECG at screening (6)
CL Item
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. (7)
CL Item
- Sinus bradycardia <45bpm (- Sinus bradycardia <45bpm)
CL Item
As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 90 mmHg. (1)
CL Item
Females (2)
CL Item
The subject has been treated for or diagnosed with depression within six month of screenin or has a history of significant psychiatric illness. (3)
CL Item
Current or chronic history of liver disease, or know hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). (4)
CL Item
Surgical procedures on digestive tract including corrective surgery for appendicitis (in the 3 months prior to screening) or diverticulitis, cholecystectomy (gallbladder removal), and/or cholelithotomy (gallstone removal). (5)
CL Item
History of current spastic/hyperactive colon. (6)
CL Item
Subjects who do not have regular defecation patterns (regular defined as passing feces at least once every two days). (7)
CL Item
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contrandicates their participation. (8)
CL Item
Any adverse reaction including immediate or delayed hypersensitivity to any ß2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of the GW642444formulation for oral administration. (9)
CL Item
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if a drug is a potential enzyme inducer) or 5 half-lives (whichever if longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures of compromise subject safety. (10)
CL Item
History of alcohol/drug abuse or dependence within 12 month of the study. Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males). One unit is equivalent to a 285 mL glass of full strength beer or 425 mL schooner of light beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine (NHMRC Guidelines [NHMRC,2001]). (11)
CL Item
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 60 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). (12)
CL Item
Exposure to more than four new chemical entities within 12 month prior to the first dosing day. (13)
CL Item
Participation in a clinical trial involving administration of 14C-labelled compound(s) withing the last 12 month. A subject's previous effective dose will be reviewed by the medical investigator to ensure there is no risk of contamination/carryover into the current study. (14)
CL Item
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. (15)
CL Item
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. (16)
CL Item
The subject has tested positive for HIV antibodies. (17)
CL Item
A positive urine drug screen at screening, on admission to the unnit, or when randomly tested during the study. (18)
CL Item
Positive alcohol urine test at screening or on admission to the Unit. (19)
CL Item
Positive urine cotinine test at screening. (20)
CL Item
Consumption of seville oranges, pomelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication. (21)
CL Item
unwillingness or inability to follow the procedures outlined in the protocol. (22)
CL Item
Subject is mentally or legally incapacitated. (23)