ID

33308

Descrizione

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

Klinische Studie [Dokumenttyp]

Pulmonale Krankheiten (Fachgebiet)

Pulmonary Disease, Chronic Obstructive

Electrocardiogram (ECG)

Vital Signs

Behandlungsbedürftigkeit, Begutachtung

Lung Diseases, Obstructive

Titolare del copyright

GlaxoSmithKline

Caricato su

5 dicembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0

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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181

model
Dettagli

Screening visit

1 moduli

StudyEvent: ODM
1. Screening visit

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Demography

Item Group

Demography

C0011298 (UMLS CUI-1)

Patient date of birth

Item

Date of birth

date

C0421451 (UMLS CUI [1])

Gender

Item

Sex

text

C0079399 (UMLS CUI [1])

Sex

Code List

Sex

CL Item

male (1)

CL Item

female (2)

Ethnic group

Item

Ethnicity

text

C0015031 (UMLS CUI [1])

Ethnicity ✓ one

Code List

Ethnicity

CL Item

Hispanic or Latino (1)

CL Item

Not Hispanic or Latino (2)

Your ancestry or national origin

Item

Geographic ancestry

text

C3841890 (UMLS CUI [1])

Geographic ancestry ✓ all that apply

Code List

Geographic ancestry

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)

Vital signs

Item Group

Vital signs

C0518766 (UMLS CUI-1)

Body Height

Item

Height

integer

C0005890 (UMLS CUI [1])

Body Weight

Item

Weight

float

C0005910 (UMLS CUI [1])

Body mass index

Item

Body mass index

float

C1305855 (UMLS CUI [1])

Vital Signs Date

Item

Date

text

C2826644 (UMLS CUI [1])

Date

Code List

Date

CL Item

1. (1)

CL Item

2. (2)

CL Item

3. (3)

Vital Signs, Relative time

Item

Planned relative time

text

C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])

Planned relative time

Code List

Planned relative time

CL Item

screening (1)

CL Item

unscheduled (2)

CL Item

unscheduled (3)

Vital Signs Time

Item

Actual Time

time

C2826762 (UMLS CUI [1])

Systolic Pressure, Supine Position

Item

Blood Pressure Supine - Systolic

integer

C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])

Diastolic Blood Pressure, Supine Position

Item

Blood Pressure Supine - Diastolic

integer

C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])

Heart Rate

Item

Heart Rate

integer

C0018810 (UMLS CUI [1])

Body Temperature, Oral

Item

Temperature Oral

float

C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])

12-lead ECG

Item Group

12-lead ECG

C0430456 (UMLS CUI-1)

12-lead ECG, Numbers

Item

ECG Number

integer

C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

Timepoint of ECG

Code List

ECG Number

CL Item

ECG one (1)

CL Item

ECG two (2)

CL Item

ECG three (3)

12lead ECG, Start Date

Item

Start Date of ECG

date

C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

12 lead ECG, Relative time

Item

Planned Relative Time ECG

text

C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])

12 lead ECG, Relative time

Code List

Planned Relative Time ECG

CL Item

Screening (1)

CL Item

Unscheduled (2)

CL Item

Unscheduled (3)

12 lead ECG, Start time

Item

Start Time of ECG

time

C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])

12 lead ECG, Heart Rate

Item

Heart Rate

integer

C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])

12 lead ECG, P-R interval

Item

PR Interval

float

C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])

12 lead ECG, QRS complex duration

Item

QRS Duration

float

C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])

12 lead ECG, QT Interval

Item

Uncorrected QT Interval

float

C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])

12 lead ECG, Measurement Method

Item

Method of measurement

integer

C0430456 (UMLS CUI [1,1])
C1299991 (UMLS CUI [1,2])

12 lead ECG, Measurement Method

Code List

Method of measurement

CL Item

Machine (1)

CL Item

Manual (2)

12 lead ECG, QTcB - Bazett's Correction Formula

Item

If machine, QTcB interval

integer

C0430456 (UMLS CUI [1,1])
C1882512 (UMLS CUI [1,2])

12 lead ECG, QTcF Fridericia's Correction Formula

Item

If machine, QTcF interval

integer

C0430456 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])

12 lead ECG, qtc interval

Item

If machine, QTc interval unknown method of correction

integer

C0430456 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])

12 lead ECG, Electrocardiogram finding

Item

Result of the ECG

integer

C0430456 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])

Result of the ECG

Code List

Result of the ECG

CL Item

Normal (1)

CL Item

Abnormal - not clinically significant (2)

CL Item

Abnormal- clinically significant (3)

CL Item

No result (not available) (4)

12-Lead ECG, Abnormality

Item Group

12-Lead ECG Abnormalities

C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)

12 lead ECG, Date in time

Item

Date of ECG

date

C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

12 Lead ECG, Time

Item

Time of ECG

time

C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

12 lead ECG, Abnormality, Electrocardiogram: Rhythm

Item

Rhythm

text

C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])

Rhythm

Code List

Rhythm

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)

12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Electrocardiogram QRS complex

Item

P-Wave and QRS Morphology

integer

C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])

P-Wave and QRS Morphology

Code List

P-Wave and QRS Morphology

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)

12 lead ECG, Abnormality, Cardiac conduction

Item

Conduction

integer

C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])

C. Conduction

Code List

Conduction

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)

12 lead ECG, Abnormality, Myocardial Infarction

Item

Myocardial Infarction

integer

C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])

D. Myocardial Infraction

Code List

Myocardial Infarction

CL Item

[D 1] Myocardial infarction, old (1)

CL Item

[D 2] Myocardial infarction, anterior (2)

CL Item

[D 3] Myocardial infarction, lateral (3)

CL Item

[D 4] Myocardial infarction, posterior (4)

CL Item

[D 5] Myocardial infarction, inferior (5)

12 lead ECG, Abnormality, Ventricular Depolarisation, Electrocardiogram Repolarisation abnormality

Item

Depolarisation/Repolarisation (QRS-T)

integer

C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])

E. Depolarisation/Repolarisation (QRS-T)

Code List

Depolarisation/Repolarisation (QRS-T)

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)

12 lead ECG, Abnormality, Other

Item

Other abnormalities

integer

C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

Other abnormalities

Code List

Other abnormalities

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)

Holter Electrocardiography, Summary Report

Item Group

Summary Holter (12HRS)

C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)

Holter Electrocardiography, Start Date

Item

Start date of Holter

date

C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Holter Electrocardiography, Start Time

Item

Start time of Holter

time

C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])

Holter Electrocardiography, End Time

Item

Stop time of Holter

time

C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])

Holter Electrocardiography, EKG finding

Item

Interpretation of Holter

text

C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])

Interpretation of Holter tick one

Code List

Interpretation of Holter

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)

Holter Electrocardiography, Test Method

Item

Holter monitoring method

text

C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])

Holter monitoring method tick one

Code List

Holter monitoring method

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)

Holter Electrocardiography, Summary Report, Electrocardiogram abnormal

Item Group

Summary Holter Abnormalities

C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
C0522055 (UMLS CUI-3)

Holter Electrocardiography, Electrocardiogram abnormal

Item

Clinically significant abnormalities

text

C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])

Clinically significant abnormalities

Code List

Clinically significant abnormalities

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

___________________________________________ (___________________________________________)

Medical conditions

Item Group

Medical conditions

Diagnosis

Item

Diagnosis

text

C0011900 (UMLS CUI [1])

Diagnosis, Current

Item

Current

boolean

C0011900 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])

Diagnosis, Past

Item

Past

boolean

C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])

Physical Examination

Item Group

Physical Examination

C0031809 (UMLS CUI-1)

Physical Examination, Assessment Date

Item

Date of Assessment

date

C0031809 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])

Physical Examination, Head

Item

Head

text

C0031809 (UMLS CUI [1,1])
C0018670 (UMLS CUI [1,2])

1. Head

Code List

Head

CL Item

Normal (1)

CL Item

Abnormal (2)

Physical Examination, Eye

Item

Eyes

text

C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])

2. Eyes

Code List

Eyes

CL Item

Normal (1)

CL Item

Abnormal (2)

Physical Examination, Ear structure

Item

Ears

text

C0031809 (UMLS CUI [1,1])
C0013443 (UMLS CUI [1,2])

3. Ears

Code List

Ears

CL Item

Normal (1)

CL Item

Abnormal (2)

Physical Examination, Nose

Item

Nose

text

C0031809 (UMLS CUI [1,1])
C0028429 (UMLS CUI [1,2])

4. Nose

Code List

Nose

CL Item

Normal (1)

CL Item

Abnormal (2)

Physical Examination, Pharyngeal structure

Item

Throat

text

C0031809 (UMLS CUI [1,1])
C0031354 (UMLS CUI [1,2])

5. Throat

Code List

Throat

CL Item

Normal (1)

CL Item

Abnormal (2)

Physical Examination, Skin

Item

Skin

text

C0031809 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])

6. Skin

Code List

Skin

CL Item

Normal (1)

CL Item

Abnormal (2)

Physical Examination, Thyroid Gland

Item

Thyroid

text

C0031809 (UMLS CUI [1,1])
C0040132 (UMLS CUI [1,2])

7. Thyroid

Code List

Thyroid

CL Item

Normal (1)

CL Item

Abnormal (2)

Physical Examination, Neurologic Examination

Item

Neurological

text

C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])

8. Neurological

Code List

Neurological

CL Item

Normal (1)

CL Item

Abnormal (2)

Physical Examination, Lung

Item

Lungs

text

C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])

9. Lungs

Code List

Lungs

CL Item

Normal (1)

CL Item

Abnormal (2)

Physical Examination, Cardiovascular System

Item

Cardiovascular

text

C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])

10. Cardiovascular

Code List

Cardiovascular

CL Item

Normal (1)

CL Item

Abnormal (2)

Physical Examination, Abdomen

Item

Abdomen (Liver and Spleen)

text

C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])

11. Abdomen (Liver and Spleen)

Code List

Abdomen (Liver and Spleen)

CL Item

Normal (1)

CL Item

Abnormal (2)

Physical Examination, Lymph Nodes

Item

Lymph Nodes

text

C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])

12. Lymph Nodes

Code List

Lymph Nodes

CL Item

Normal (1)

CL Item

Abnormal (2)

Physical Examination, Examination of the extremities

Item

Extremities

text

C0031809 (UMLS CUI [1,1])
C0436150 (UMLS CUI [1,2])

13. Extremities

Code List

Extremities

CL Item

Normal (1)

CL Item

Abnormal (2)

History of Tobacco Use

Item Group

History of Tobacco Use

C0841002 (UMLS CUI-1)

History of tobacco use

Item

What is the subject's history of smoking use?

text

C0841002 (UMLS CUI [1])

History of tobacco use

Code List

What is the subject's history of smoking use?

CL Item

Never smoked (1)

CL Item

Former smoker (2)

Tobacco use, Last, Date in time

Item

When did the subject last smoke?

date

C0543414 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Pack Years

Item

Number of pack years?

float

C1277691 (UMLS CUI [1])

HIV screen

Item Group

Serology - HIV Screen

C0459958 (UMLS CUI-1)

HIV screen, Sampling, Date in time

Item

Date sample taken

date

C0459958 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Alcohol consumption

Item Group

Alcohol Intake

C0001948 (UMLS CUI-1)

Alcohol consumption

Item

Does the subject consume alcohol?

boolean

C0001948 (UMLS CUI [1])

Alcohol consumption, alcohol units/week

Item

If yes, record the average number of units of alcohol consumed per week

float

C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])

Drug screen, Ethanol measurement

Item Group

Drug and Alcohol Screen

C0373483 (UMLS CUI-1)
C0202304 (UMLS CUI-2)

Drug Screen, Ethanol measurement, Date in time, Time

Item

datetime

C0373483 (UMLS CUI [1,1])
C0202304 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

Laboratory Procedures; Chemistry, Clinical

Item Group

Electronically transferred laboratory data - Clinical Chemistry

C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)

Laboratory Procedure; Chemistry, Clinical; Relative Time

Item

Planned Relative Time

text

C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])

Laboratory Procedure; Chemistry, Clinical; Relative Time

Code List

Planned Relative Time

CL Item

Screening (Screening)

CL Item

Unscheduled (Unscheduled)

Laboratory Procedures; Chemistry, Clinical; Sampling; Date in time

Item

Date Sample Taken

date

C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])

Laboratory Procedures; Chemistry, Clinical; Time

Item

Actual Time

time

C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])

Laboratory Procedures; Haematologic tests

Item Group

Electronically transferred laboratory data - Haematology

C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)

Laboratory Procedure; Hematologic Tests; Relative Time

Item

Planned Relative Time

text

C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])

Laboratory Procedure; Chemistry, Clinical; Relative Time

Code List

Planned Relative Time

CL Item

Screening (Screening)

CL Item

Unscheduled (Unscheduled)

Laboratory Procedures; Hematologic Tests; Sampling; Date in time

Item

Date Sample Taken

date

C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])

Laboratory Procedures; Hematologic Tests; Time

Item

Actual Time

time

C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])

Laboratory Procedures; Urinalysis

Item Group

Electronically transferred laboratory data - Urinalysis

C0022885 (UMLS CUI-1)
C0042014 (UMLS CUI-2)

Laboratory Procedure; Urinalysis; Relative Time

Item

Planned Relative Time

text

C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])

Laboratory Procedure; Chemistry, Clinical; Relative Time

Code List

Planned Relative Time

CL Item

Screening (Screening)

CL Item

Unscheduled (Unscheduled)

Laboratory Procedures; Urinalysis; Sampling; Date in time

Item

Date Sample Taken

date

C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])

Laboratory Procedures; Urinalysis; Time

Item

Actual Time

time

C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])

Pharmacokinetic aspects, Blood

Item Group

Pharmacokinetics - Blood

C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)

Pharmacokinetic aspects, Blood, Relative time

Item

Planned Relative Time

text

C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])

Pharmacokinetic aspects, Blood, Relative time

Code List

Planned Relative Time

CL Item

Screening (1)

CL Item

Unscheduled (2)

CL Item

Unscheduled (3)

Pharmacokinetic aspects, Blood, Sampling, Date in time

Item

Date Sample Taken

date

C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])

Pharmacokinetic aspects, Blood, Sampling, Time

Item

Actual Time

time

C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

Pharmacokinetic aspects, Blood, Sampling, Numbers

Item

Sample Number

integer

C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])

Inclusion

Item Group

Inclusion Criteria

C1512693 (UMLS CUI-1)

Gender, Health Status, Age

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.

boolean

C0079399 (UMLS CUI [1,1])
C0018759 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])

Body mass index

Item

Body Mass Index (BMI) within the range 18.5-29.0 kg/m2 (inclusive).

boolean

C1305855 (UMLS CUI [1])

Tobacco use

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].

boolean

C0543414 (UMLS CUI [1])

Alanine aminotransferase measurement, Aspartate aminotransferase measurement, Alkaline phosphatase measurement, Serum total bilirubin measurement

Item

AST, ALT, alkaline phosphatase and bilirubin < = 1.5xULN (isolated bilirubin>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

boolean

C0201836 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201850 (UMLS CUI [1,3])
C1278039 (UMLS CUI [1,4])

12 lead ECG, Abnormality

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: - Sinus tachycardia > = 110 bpm - Multifocal atrial tachycadria (wandering atrial pacemaker with rate >100 bpm) = - Multifocal atrial tachycadria (wandering atrial pacemaker with rate >100 bpm) - PR interval >240 msec = - PR interval >240 msec - Evidence of Mobitz II second degree or third degree atroventricular (AV) block = - Evidence of Mobitz II second degree or third degree atroventricular (AV) block - 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. - Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. = - Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. - QTcF > = 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 - ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities = - ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities - Right or left complete bundle branch block = - Right or left complete bundle branch block - 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

boolean

C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Holter Electrocardiography, ECG abnormality

Item

No significant abnormality on the Holter ECG at screening

boolean

C0013801 (UMLS CUI [1,1])
C1832603 (UMLS CUI [1,2])

Informed Consent

Item

Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

Exclusion Criteria

C0680251 (UMLS CUI-1)

Unsuitable for study, Blood Pressure

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.

boolean

C2348568 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])

Gender

Item

Females

boolean

C0079399 (UMLS CUI [1])

Depressive disorder, Significant, Mental disorders

Item

The subject has been treated for or diagnosed with depression within six month of screenin or has a history of significant psychiatric illness.

boolean

C0011581 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])

Liver diseases; Abnormality of the liver; Biliary tract abnormality

Item

Current or chronic history of liver disease, or know hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

boolean

C0023895 (UMLS CUI [1,1])
C4021780 (UMLS CUI [1,2])
C0549613 (UMLS CUI [1,3])

Operative Surgical Procedures; Gastrointestinal tract structure

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).

boolean

C0543467 (UMLS CUI [1,1])
C0017189 (UMLS CUI [1,2])

spastic colon syndrome

Item

History of current spastic/hyperactive colon.

boolean

C0848327 (UMLS CUI [1])

Defecation, irregular

Item

Subjects who do not have regular defecation patterns (regular defined as passing feces at least once every two days).

boolean

C0011135 (UMLS CUI [1,1])
C0205271 (UMLS CUI [1,2])

Experimental Drug, Hypersensitivity; Hypersensitivity, Other

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.

boolean

C0304229 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])

Adrenergic beta2-Agonists [MoA], Hypersensitivity; Amines, Sympathomimetic, Hypersensitivity; Experimental drug, Hypersensitivity

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.

boolean

C1373132 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0002509 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])

Pharmaceutic Preparations; Vitamins, Herbal supplements, Dietary Supplements

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.

boolean

C0013227 (UMLS CUI [1,1])
C0042890 (UMLS CUI [1,2])
C1504473 (UMLS CUI [1,3])
C0242295 (UMLS CUI [1,4])

alcohol abuse; Drug abuse

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]).

boolean

C0085762 (UMLS CUI [1])
C0013146 (UMLS CUI [2])

Study Subject Participation Status

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).

boolean

C2348568 (UMLS CUI [1])

Pharmaceutical Preparations, Exposure

Item

Exposure to more than four new chemical entities within 12 month prior to the first dosing day.

boolean

C0013227 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])

Compound, Labeled, Carbon-14

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.

boolean

C1706082 (UMLS CUI [1,1])
C1708632 (UMLS CUI [1,2])
C0302945 (UMLS CUI [1,3])

Blood Donation; Blood product

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.

boolean

C0005794 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])

Hepatitis B surface antigen positive; Hepatitis C antibody positive

Item

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.

boolean

C0149709 (UMLS CUI [1,1])
C0281863 (UMLS CUI [1,2])

HIV Seropositivity

Item

The subject has tested positive for HIV antibodies.

boolean

C0019699 (UMLS CUI [1])

Urine drug screen positive

Item

A positive urine drug screen at screening, on admission to the unnit, or when randomly tested during the study.

boolean

C0743300 (UMLS CUI [1])

Urine drug screen positive

Item

Positive alcohol urine test at screening or on admission to the Unit.

boolean

C0743300 (UMLS CUI [1])

Urine cotinine test

Item

Positive urine cotinine test at screening.

boolean

C1697737 (UMLS CUI [1])

Grapefruit, Grapefruit Juice

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.

boolean

C0995150 (UMLS CUI [1,1])
C0452456 (UMLS CUI [1,2])

Compliance behavior

Item

Unwillingness or inability to follow the procedures outlined in the protocol.

boolean

C1321605 (UMLS CUI [1])

Mental Handicap; Legal Capacity, Lacking

Item

Subject is mentally or legally incapacitated.

boolean

C1306341 (UMLS CUI [1])
C0683673 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])

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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181

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