ID

40351

Beschreibung

Study ID: 111314 Clinical Study ID: 111314 Study Title: A first-time-in-human, three-part, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00857883 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1521498 or placebo Study Indication: Obesity

Stichworte

Versionen (1)
  1. 11.04.20 11.04.20 -
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GlaxoSmithKline

Hochgeladen am

11. April 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883

Englisch

Pharmacogenetics; Inclusion; Temperature; Status of Treatment Blind; Study Conclusion

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Study
Beschreibung

Study

Datentyp

text

Alias
UMLS CUI [1]
C2603343
Subject
Beschreibung

Subject

Datentyp

text

Alias
UMLS CUI [1]
C0681850
Collected by
Beschreibung

Collected by

Datentyp

text

Alias
UMLS CUI [1]
C3244127
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Study Phase
Beschreibung

Study Phase

Datentyp

text

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C2603343
Session
Beschreibung

Session

Datentyp

text

Alias
UMLS CUI [1]
C1883017
PGx Consent
Beschreibung

PGx Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
PGx Consent - Physical Date
Beschreibung

PGx Consent - Physical Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
PGx Consent - Time
Beschreibung

PGx Consent - Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0040223
PGx Consent - Day
Beschreibung

PGx Consent - Day

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0439228
PGx Consent - Hour
Beschreibung

PGx Consent - Hour

Datentyp

integer

Maßeinheiten
  • h
Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0439227
h
PGx Consent - Min
Beschreibung

PGx Consent - Min

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0439232
min
PGx Consent - Informed Consent obtained?
Beschreibung

PGx Consent - Informed Consent obtained?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
PGx Consent - Date obtained
Beschreibung

PGx Consent - Date obtained

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
PGx Consent - Blood sample collection date
Beschreibung

PGx Consent - Blood sample collection date

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0005834
PGx Consent - Withdrawal of PGx consent?
Beschreibung

PGx Consent - Withdrawal of PGx consent?

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C2349954
PGx Consent - Request for sample destruction?
Beschreibung

PGx Consent - Request for sample destruction?

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [2,1]
C1272683
UMLS CUI [2,2]
C1948029
UMLS CUI [2,3]
C0178913
PGx Consent - Reason for sample destruction
Beschreibung

PGx Consent - Reason for sample destruction

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [2,1]
C1948029
UMLS CUI [2,2]
C0178913
UMLS CUI [2,3]
C0392360
Inclusion
Beschreibung

Inclusion

Alias
UMLS CUI-1
C1512693
Inclusion - Physical Date
Beschreibung

Inclusion - Physical Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0011008
Inclusion - Time
Beschreibung

Inclusion - Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0040223
Inclusion - Day
Beschreibung

Inclusion - Day

Datentyp

text

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0439228
Inclusion- Hour
Beschreibung

Inclusion- Hour

Datentyp

integer

Maßeinheiten
  • h
Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0439227
h
Inclusion - Min
Beschreibung

Inclusion - Min

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0439232
min
Did the subject meet all the entry criteria
Beschreibung

Did the subject meet all the entry criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Temperature
Beschreibung

Temperature

Alias
UMLS CUI-1
C0005903
Temperature - Physical Date
Beschreibung

Temperature - Physical Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0011008
Temperature - Time
Beschreibung

Temperature - Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0040223
Temperature - Day
Beschreibung

Temperature - Day

Datentyp

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439228
Temperature - Hour
Beschreibung

Temperature - Hour

Datentyp

integer

Maßeinheiten
  • h
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439227
h
Temperature - Min
Beschreibung

Temperature - Min

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439232
min
Tympanic Temperature
Beschreibung

Tympanic Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0041445
UMLS CUI [1,2]
C0005903
°C
Status of Treatment Blind
Beschreibung

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Status of Treatment Blind - Physical Date
Beschreibung

Status of Treatment Blind - Physical Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C0011008
Status of Treatment Blind - Time
Beschreibung

Status of Treatment Blind - Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C0040223
Status of Treatment Blind - Day
Beschreibung

Status of Treatment Blind - Day

Datentyp

text

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C0439228
Status of Treatment Blind - Hour
Beschreibung

Status of Treatment Blind - Hour

Datentyp

integer

Maßeinheiten
  • h
Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C0439227
h
Status of Treatment Blind - Min
Beschreibung

Status of Treatment Blind - Min

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C0439232
min
Was the Treatment blind broken during the study?
Beschreibung

If Yes complete AE,SAE and/or Investigational product forms as appropriate

Datentyp

boolean

Alias
UMLS CUI [1]
C3897431
Date and Time blind broken
Beschreibung

Date and Time blind broken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C1264639
Reason blind broken
Beschreibung

Reason blind broken

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Study Conclusion - Physical Date
Beschreibung

Study Conclusion - Physical Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0011008
Study Conclusion - Time
Beschreibung

Study Conclusion - Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0040223
Study Conclusion - Day
Beschreibung

Study Conclusion - Day

Datentyp

text

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0439228
Study Conclusion - Hour
Beschreibung

Study Conclusion - Hour

Datentyp

integer

Maßeinheiten
  • h
Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0439227
h
Study Conclusion - Min
Beschreibung

Study Conclusion - Min

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0439232
min
Date of last contact (FU date if completed as planned)
Beschreibung

Date of last contact (FU date if completed as planned)

Datentyp

date

Alias
UMLS CUI [1]
C0805839
UMLS CUI [2]
C3694716
Was the subject withdrawn from the study?
Beschreibung

Was the subject withdrawn from the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C0422727
Date of decision to withdraw
Beschreibung

Date of decision to withdraw

Datentyp

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
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Ähnliche Modelle

Pharmacogenetics; Inclusion; Temperature; Status of Treatment Blind; Study Conclusion

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study
Item
Study
text
C2603343 (UMLS CUI [1])
Subject
Item
Subject
text
C0681850 (UMLS CUI [1])
Collected by
Item
Collected by
text
C3244127 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Study Phase
Item
Study Phase
text
C0205390 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Session
Item
Session
text
C1883017 (UMLS CUI [1])
Item Group
PGx Consent
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
PGx Consent - Physical Date
Item
PGx Consent - Physical Date
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
PGx Consent - Time
Item
PGx Consent - Time
time
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
PGx Consent - Day
Item
PGx Consent - Day
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
PGx Consent - Hour
Item
PGx Consent - Hour
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
PGx Consent - Min
Item
PGx Consent - Min
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Item
PGx Consent - Informed Consent obtained?
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
PGx Consent - Informed Consent obtained?
Code List
PGx Consent - Informed Consent obtained?
CL Item
No- Subject Declined  (01)
CL Item
Yes  (04)
CL Item
No- Other  (03)
CL Item
No- Subject not asked by investigator (02)
PGx Consent - Date obtained
Item
PGx Consent - Date obtained
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
PGx Consent - Blood sample collection date
Item
PGx Consent - Blood sample collection date
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Item
PGx Consent - Withdrawal of PGx consent?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
PGx Consent - Withdrawal of PGx consent?
Code List
PGx Consent - Withdrawal of PGx consent?
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
Item
PGx Consent - Request for sample destruction?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C1272683 (UMLS CUI [2,1])
C1948029 (UMLS CUI [2,2])
C0178913 (UMLS CUI [2,3])
PGx Consent - Request for sample destruction?
Code List
PGx Consent - Request for sample destruction?
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
Item
PGx Consent - Reason for sample destruction
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C1948029 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
PGx Consent - Reason for sample destruction
Code List
PGx Consent - Reason for sample destruction
CL Item
Subject's Request  (01)
CL Item
Not Applicable  (04)
CL Item
Other  (03)
CL Item
Screen Failure (02)
Item Group
Inclusion
C1512693 (UMLS CUI-1)
Inclusion - Physical Date
Item
Inclusion - Physical Date
date
C1512693 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Inclusion - Time
Item
Inclusion - Time
time
C1512693 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Inclusion - Day
Item
Inclusion - Day
text
C1512693 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Inclusion- Hour
Item
Inclusion- Hour
integer
C1512693 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Inclusion - Min
Item
Inclusion - Min
integer
C1512693 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Did the subject meet all the entry criteria
Item
Did the subject meet all the entry criteria
boolean
C1516637 (UMLS CUI [1])
Item Group
Temperature
C0005903 (UMLS CUI-1)
Temperature - Physical Date
Item
Temperature - Physical Date
date
C0005903 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature - Time
Item
Temperature - Time
time
C0005903 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Temperature - Day
Item
Temperature - Day
text
C0005903 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Temperature - Hour
Item
Temperature - Hour
integer
C0005903 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Temperature - Min
Item
Temperature - Min
integer
C0005903 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Tympanic Temperature
Item
Tympanic Temperature
float
C0041445 (UMLS CUI [1,1])
C0005903 (UMLS CUI [1,2])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Status of Treatment Blind - Physical Date
Item
Status of Treatment Blind - Physical Date
date
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Status of Treatment Blind - Time
Item
Status of Treatment Blind - Time
time
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Status of Treatment Blind - Day
Item
Status of Treatment Blind - Day
text
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Status of Treatment Blind - Hour
Item
Status of Treatment Blind - Hour
integer
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Status of Treatment Blind - Min
Item
Status of Treatment Blind - Min
integer
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Was the Treatment blind broken during the study?
Item
Was the Treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date and Time blind broken
Item
Date and Time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify score 1 (2)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Study Conclusion - Physical Date
Item
Study Conclusion - Physical Date
date
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Study Conclusion - Time
Item
Study Conclusion - Time
time
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Study Conclusion - Day
Item
Study Conclusion - Day
text
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Study Conclusion - Hour
Item
Study Conclusion - Hour
integer
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Study Conclusion - Min
Item
Study Conclusion - Min
integer
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Date of last contact (FU date if completed as planned)
Item
Date of last contact (FU date if completed as planned)
date
C0805839 (UMLS CUI [1])
C3694716 (UMLS CUI [2])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Date of decision to withdraw
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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