ID
38074
Beskrivning
Two-Part Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Oral Dosesof the Enteric-Coated Free Base Formulation of Darapladib (SB-480848) ina Dose Rising Fashion and to Evaluate the Safety, Tolerability and Pharmacokinetics of Darapladib when Co-administered with Ketoconazole in Healthy Adult Subjects. There are 4 parts to this study: Screening, Part A, Part B, and Follow-Up. Part A contains 2 Sessions per day for day 1-10, Part B contains 1 Session per day for day 1-14. Each itemgroup contains information when it should be filled out. The itemgroups of the non-serious and serious adverse event forms contain additional information on the definition of a serious/non-serious adverse event.
Nyckelord
Versioner (1)
- 2019-09-15 2019-09-15 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 september 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Darapladib Evaluation Case Report Form GSK LPL107988
Study Conclusion
Beskrivning
Pharmacogenetic Research
Alias
- UMLS CUI-1
- C4084975
Beskrivning
If Yes, record the date informed consent obtained for PGx research
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C4084975
- UMLS CUI [1,2]
- C0021430
Beskrivning
Date of informed consent
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Beskrivning
If other please specify below
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1705492
- UMLS CUI [1,3]
- C0566251
Beskrivning
Reason other specified
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
If Yes, record the date sample taken
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C4084975
Beskrivning
Date sample collected
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0011008
Beskrivning
If Yes, record the date informed consent withdrawn for PGx research
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C4084975
- UMLS CUI [1,2]
- C1707492
Beskrivning
Date consent withdrawn
Datatyp
date
Alias
- UMLS CUI [1,1]
- C4084975
- UMLS CUI [1,2]
- C1707492
- UMLS CUI [1,3]
- C0011008
Beskrivning
Sample Destruction
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0686900
- UMLS CUI [1,2]
- C2347026
- UMLS CUI [1,3]
- C1948029
Beskrivning
Request for sample destruction reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0686900
- UMLS CUI [1,2]
- C2347026
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C0566251
Beskrivning
Other reason specified
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beskrivning
If Yes, complete Pregnancy Notification form.
Datatyp
integer
Alias
- UMLS CUI [1]
- C3828490
Beskrivning
If Yes, complete Pregnancy Notification form.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0086287
- UMLS CUI [1,2]
- C3887537
- UMLS CUI [1,3]
- C3828490
Beskrivning
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0449438
- UMLS CUI-2
- C0150108
- UMLS CUI-3
- C0749659
Beskrivning
If Yes, complete the following items
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0150108
- UMLS CUI [1,2]
- C0749659
- UMLS CUI [1,3]
- C0443289
Beskrivning
Date and time blind broken
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0150108
- UMLS CUI [1,3]
- C0749659
- UMLS CUI [1,4]
- C0443289
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0150108
- UMLS CUI [2,3]
- C0749659
- UMLS CUI [2,4]
- C0443289
Beskrivning
If other specify in the next item. Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0150108
- UMLS CUI [1,3]
- C0749659
- UMLS CUI [1,4]
- C0443289
Beskrivning
Other reason specified
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C2603343
Beskrivning
Completion or withdrawal
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2348577
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C0422727
Beskrivning
Withdrawn
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
Primary withdrawal reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Beskrivning
Reason other specified
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Similar models
Study Conclusion
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C4084975 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1707492 (UMLS CUI [1,2])
C1707492 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2347026 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C2347026 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])
C0150108 (UMLS CUI-2)
C0749659 (UMLS CUI-3)
C0749659 (UMLS CUI [1,2])
C0443289 (UMLS CUI [1,3])
C0150108 (UMLS CUI [1,2])
C0749659 (UMLS CUI [1,3])
C0443289 (UMLS CUI [1,4])
C0040223 (UMLS CUI [2,1])
C0150108 (UMLS CUI [2,2])
C0749659 (UMLS CUI [2,3])
C0443289 (UMLS CUI [2,4])
C0150108 (UMLS CUI [1,2])
C0749659 (UMLS CUI [1,3])
C0443289 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C2348577 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
C1549995 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])