ID
37660
Description
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis
Keywords
Versions (5)
- 4/15/19 4/15/19 -
- 4/17/19 4/17/19 -
- 4/23/19 4/23/19 -
- 8/14/19 8/14/19 -
- 8/14/19 8/14/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 14, 2019
DOI
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License
Creative Commons BY-NC 3.0
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The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543
Screen - Date of Visit; Demography, 12-Lead ECG; Vital Signs; Subject Identification; Electronically Transferred Lab Data
Description
Subject number
Alias
- UMLS CUI-1
- C2348585
Description
Date of Visit/ Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
If subject is female, record childbearing potential
Data type
integer
Alias
- UMLS CUI [1]
- C3831118
Description
Ethnicity
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Geographic ancestry
Data type
integer
Alias
- UMLS CUI [1]
- C3841890
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
Date and Time of ECG
Data type
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
RR Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0489636
Description
PR Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C1287082
Description
QTc (b) Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0489625
Description
Method of QTc Calculation
Data type
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Result of the ECG
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Actual date/time
Data type
datetime
Alias
- UMLS CUI [1]
- C1264639
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body mass index
Data type
integer
Alias
- UMLS CUI [1]
- C1305855
Description
Systolic Blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Respiration rate
Data type
integer
Measurement units
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Subject identification
Alias
- UMLS CUI-1
- C2348585
Description
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
Description
Haematology Date and time sample taken
Data type
date
Alias
- UMLS CUI [1]
- C0018941
- UMLS CUI [2,1]
- C0005834
- UMLS CUI [2,2]
- C0011008
- UMLS CUI [2,3]
- C0040223
Description
Haematology sample not done
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0018941
- UMLS CUI [1,3]
- C1272696
Description
Clinical Chemistry Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1]
- C0008000
- UMLS CUI [2,1]
- C0200345
- UMLS CUI [2,2]
- C0011008
- UMLS CUI [2,3]
- C0040223
Description
Clinical Chemistry sample not done
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Description
Urinalysis Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Description
Urinanalysis sample not done
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
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Screen - Date of Visit; Demography, 12-Lead ECG; Vital Signs; Subject Identification; Electronically Transferred Lab Data
C2986440 (UMLS CUI [1,2])
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
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C1320722 (UMLS CUI-3)
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