ID

36234

Descripción

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 Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Palabras clave

Versiones (1)
  1. 23/4/19 23/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

23 de abril de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Follow-up - Electronically Transferred Lab Data; 12-Lead ECG; Vital Signs; Study Conclusion; Pregnancy Information

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Electronically Transferred Lab Data - Pre dose
Descripción

Electronically Transferred Lab Data - Pre dose

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
UMLS CUI-4
C0439565
Haematology Date and time sample taken
Descripción

Haematology Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haematology sampling not done
Descripción

Haematology sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Descripción

Clinical Chemistry Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry sampling not done
Descripción

Clinical Chemistry sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Urinalysis Date and time sample taken
Descripción

Urinalysis Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Urinalysis sampling not done
Descripción

Urinalysis sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Electronically Transferred Lab Data - 24 hrs (Day 2)
Descripción

Electronically Transferred Lab Data - 24 hrs (Day 2)

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Haematology Date and time sample taken
Descripción

Haematology Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haematology sampling not done
Descripción

Haematology sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Descripción

Clinical Chemistry Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry sampling not done
Descripción

Clinical Chemistry sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Urinalysis Date and time sample taken
Descripción

Urinalysis Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Urinalysis sampling not done
Descripción

Urinalysis sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Electronically Transferred Lab Data - 72 hrs (Day 4)
Descripción

Electronically Transferred Lab Data - 72 hrs (Day 4)

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
AST/ ALT Date and time sample taken
Descripción

AST/ ALT Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0200345
UMLS CUI [3]
C0201836
AST/ ALT sampling not done
Descripción

AST/ ALT sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C1272696
UMLS CUI [2,1]
C0201899
UMLS CUI [2,2]
C0022885
UMLS CUI [2,3]
C0870078
UMLS CUI [2,4]
C1272696
12-Lead ECG
Descripción

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Descripción

Date and Time of ECG

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Heart Rate
Descripción

Heart Rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Descripción

RR Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0489636
ms
PR Interval
Descripción

PR Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Descripción

QRS Duration

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Descripción

Uncorrected QT Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc (b) Interval
Descripción

QTc (b) Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Descripción

Method of QTc Calculation

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Descripción

Result of the ECG

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/ time
Descripción

Actual date/ time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic Blood Pressure
Descripción

Systolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Descripción

Respiration rate

Tipo de datos

integer

Unidades de medida
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Study Conclusion
Descripción

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or date and time of subject withdrawal
Descripción

Date of subject completion or date and time of subject withdrawal

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2983670
UMLS CUI [2,1]
C0422727
UMLS CUI [2,2]
C0011008
Was the subject withdrawn from the study?
Descripción

Was the subject withdrawn from the study?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0422727
If subject was withdrawn from study, specify primary reason for withdrawal
Descripción

If subject was withdrawn from study, specify primary reason for withdrawal

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
If other reason for withdrawal, please specify
Descripción

If other reason for withdrawal, please specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
Case book ready for signature
Descripción

Data owner should check the box when data cleaning is complete

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
Office Use 1
Descripción

Office Use 1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0442603
Office Use 2
Descripción

Office Use 2

Tipo de datos

text

Alias
UMLS CUI [1]
C0442603
Pregnancy Information (F)
Descripción

Pregnancy Information (F)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Descripción

If Yes, complete the paper Pregnancy Notification form

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
Pregnancy Information (M)
Descripción

Pregnancy Information (M)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner of the male subject become pregnant during the study?
Descripción

Check Not Applicable if female partner not of childbearing potential or no female partner

Tipo de datos

text

Alias
UMLS CUI [1]
C0919624
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Similar models

Follow-up - Electronically Transferred Lab Data; 12-Lead ECG; Vital Signs; Study Conclusion; Pregnancy Information

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Electronically Transferred Lab Data - Pre dose
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0439565 (UMLS CUI-4)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haematology sampling not done
integer
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Haematology sample not done
Code List
Haematology sampling not done
CL Item
Haematology sampling not done (1)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Clinical Chemistry sampling not done
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Clinical Chemistry sampling not done
Code List
Clinical Chemistry sampling not done
CL Item
Clinical Chemistry sampling not done (1)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Urinalysis sampling not done
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinalysis sampling not done
Code List
Urinalysis sampling not done
CL Item
Urinalysis sampling not done (1)
Item Group
Electronically Transferred Lab Data - 24 hrs (Day 2)
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haematology sampling not done
integer
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Haematology sampling not done
Code List
Haematology sampling not done
CL Item
Haematology sampling not done (1)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Clinical Chemistry sampling not done
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Clinical Chemistry sampling not done
Code List
Clinical Chemistry sampling not done
CL Item
Clinical Chemistry sampling not done (1)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Urinalysis sampling not done
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinalysis sampling not done
Code List
Urinalysis sampling not done
CL Item
Urinalysis sampling not done (1)
Item Group
Electronically Transferred Lab Data - 72 hrs (Day 4)
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
AST/ ALT Date and time sample taken
Item
AST/ ALT Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Item
AST/ ALT sampling not done
integer
C0201899 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
C0201899 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C0870078 (UMLS CUI [2,3])
C1272696 (UMLS CUI [2,4])
AST/ ALT sampling not done
Code List
AST/ ALT sampling not done
CL Item
AST/ ALT sampling not done (1)
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
C0489636 (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 (b) Interval
Item
QTc (b) Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual date/ time
Item
Actual date/ time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or date and time of subject withdrawal
Item
Date of subject completion or date and time of subject withdrawal
datetime
C2983670 (UMLS CUI [1])
C0422727 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If subject was withdrawn from study, specify primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
If subject was withdrawn from study, specify primary reason for withdrawal
Code List
If subject was withdrawn from study, specify primary reason for withdrawal
CL Item
Adverse event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (6)
CL Item
Other, specify (7)
If other reason for withdrawal, please specify
Item
If other reason for withdrawal, please specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Case book ready for signature
text
C1519316 (UMLS CUI [1])
Case book ready for signature
Code List
Case book ready for signature
CL Item
Yes (Y)
Office Use 1
Item
Office Use 1
boolean
C0442603 (UMLS CUI [1])
Office Use 2
Item
Office Use 2
text
C0442603 (UMLS CUI [1])
Item Group
Pregnancy Information (F)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1])
Item Group
Pregnancy Information (M)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Did a female partner of the male subject become pregnant during the study?
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (X)
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