ID
31984
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 (5)
- 10/10/18 10/10/18 -
- 10/10/18 10/10/18 -
- 10/10/18 10/10/18 -
- 10/10/18 10/10/18 -
- 12/11/18 12/11/18 -
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
Study period description
- StudyEvent: ODM
Description
Electronically transferred laboratory data Day 1
Description
Vital signs Day 1
Description
Date
Data type
date
Description
Planned relative time
Data type
integer
Description
Actual time
Data type
integer
Description
Supine mmHg
Data type
text
Description
Systolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Temperature
Data type
text
Alias
- UMLS CUI [1]
- C0039476
Description
12-Lead-ECG
Alias
- UMLS CUI-1
- C0430456
Description
Start date of ECG
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0013798
Description
Planned Relative Time
Data type
time
Alias
- UMLS CUI [1]
- C0439564
Description
Start Time of ECG
Data type
time
Measurement units
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0013798
Description
Ventricular Rate
Data type
integer
Measurement units
- Beats/min
Alias
- UMLS CUI [1]
- C2189285
Description
PR Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C1287082
Description
QTc Invertal
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0860814
Description
1 = Machine 2 = Manual For Machine reads QTcB Interval, and/or QTcF can be collected
Data type
text
Description
QTcB Interval
Data type
integer
Measurement units
- msec
Description
QTcF Interval
Data type
integer
Measurement units
- msec
Description
QTc Interval unknown method of correction
Data type
integer
Measurement units
- msec
Description
Enter code for result from the following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
12 LEAD ECG Day 1
Description
ECG number
Data type
integer
Description
ECG 1
Data type
integer
Description
Start date of ECG
Data type
text
Description
Planned Relative Time
Data type
text
Description
Start Time of ECG
Data type
time
Description
Heart rate
Data type
integer
Measurement units
- bpm
Description
PR Interval
Data type
integer
Measurement units
- msec
Description
QRS Duration
Data type
integer
Measurement units
- msec
Description
QRS Duration
Data type
integer
Measurement units
- msec
Description
Uncorrected QT Interval
Data type
integer
Measurement units
- msec
Description
1 = Machine 2 = Manual For Machine reads QTcB Interval, and/or QTcF can be collected
Data type
text
Description
QTcB Interval
Data type
integer
Measurement units
- msec
Description
QTcF Interval
Data type
integer
Measurement units
- msec
Description
QTc Interval unknown method of correction
Data type
integer
Measurement units
- msec
Description
enter code for result from the following list: 1=normal, 2=abnormal-not clinically significant, 3=abnormal-clinically significant, 4= no result (not available)
Data type
integer
Description
12 LEAD ECG Abnormalities Day 1
Description
Date of ECG
Data type
date
Description
Time of ECG
Data type
time
Description
Rhythm
Data type
text
Description
P-Wave and QRS Morphology
Data type
text
Description
Conduction
Data type
text
Description
Myocardial Infraction
Data type
text
Description
Depolarisation/Repolarisation (QRS-T)
Data type
text
Description
Other abnormalities
Data type
text
Description
Treatment details
Description
record randomisation number
Data type
integer
Description
Investigational product Day 1
Data type
text
Description
e.g. 5 JUN 08
Data type
date
Description
e.g 10:54
Data type
time
Description
Actual dose
Data type
integer
Description
Units
Data type
integer
Measurement units
- mg
Description
PO
Data type
text
Description
SOL
Data type
text
Description
Did the subject receive the correct treatment (e.g., treatment that the subject was assigned to) during this dosing interval
Data type
text
Description
If "No" record reasons
Data type
text
Description
Pharmacokinetics Day 1
Description
Blood - Day1
Data type
text
Description
time relative to dosing
Data type
integer
Description
Date sample taken
Data type
date
Description
Actual time
Data type
time
Description
Sample number
Data type
integer
Description
Blood - Metabolite samples
Data type
text
Description
time relative to dosing
Data type
text
Description
Date sample taken
Data type
date
Description
Actual time
Data type
time
Description
Sample number
Data type
integer
Description
Urine
Data type
text
Description
Pharmacokinetic Sampling Urine Interval Collection Data - Day 1
Data type
text
Description
time relative to dosing
Data type
text
Description
Start date
Data type
date
Description
Actual start time
Data type
time
Description
Stop date
Data type
date
Description
Actual stop time
Data type
time
Description
Toltal sample weight
Data type
float
Measurement units
- g
Description
Sample number
Data type
text
Description
Faeces
Data type
text
Description
Pharmacokintec sampling faeces interval collection data - Day1
Data type
text
Description
time relative to dosing
Data type
text
Description
Start Date
Data type
date
Description
Actual start time
Data type
time
Description
Stop Date
Data type
date
Description
Actual stop time
Data type
time
Description
Total sample weight
Data type
float
Measurement units
- g
Description
Sample number
Data type
text
Description
2 hrs - 6.5 hrs post-dose
Data type
text
Description
time relative to dosing
Data type
text
Measurement units
- hrs
Description
Procedure
Data type
text
Description
e.g., 01 JAN 10
Data type
date
Description
e.g, 10:35
Data type
time
Description
16:35
Data type
time
Similar models
Study period description
- StudyEvent: ODM
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])