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
Demography
Beskrivning
Center Number
Alias
- UMLS CUI-1
- C2347790
- UMLS CUI-2
- C0237753
Beskrivning
Demography
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Sex
Datatyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Ethnicity
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beskrivning
Geographic Ancestry African American/African Heritage
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C0085756
Beskrivning
Geopgraphic Ancestry American Indian or Alaskan Native
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C0002460
- UMLS CUI [2,1]
- C1517526
- UMLS CUI [2,2]
- C0870134
- UMLS CUI [2,3]
- C0682125
Beskrivning
Geopgraphic Ancestry Asian - Central/South Asian Heritage
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C0238696
- UMLS CUI [2,1]
- C1517526
- UMLS CUI [2,2]
- C0870134
- UMLS CUI [2,3]
- C1519427
Beskrivning
Geopgraphic Ancestry Asian - East Asian Heritage
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C4540996
Beskrivning
Geopgraphic Ancestry Asian - Japanese Heritage
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C1556094
Beskrivning
Geopgraphic Ancestry Asian - South East Asian Heritage
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C0238697
Beskrivning
Geopgraphic Ancestry Native Hawaiian or Other Pacific Islander
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C1513907
Beskrivning
Geopgraphic Ancestry White - Arabic/North African Heritage
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C1561448
- UMLS CUI [2,1]
- C1517526
- UMLS CUI [2,2]
- C0870134
- UMLS CUI [2,3]
- C0238604
Beskrivning
Geographic Ancestry White - White/Caucasian/European Heritage
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C0043157
- UMLS CUI [2,1]
- C1517526
- UMLS CUI [2,2]
- C0870134
- UMLS CUI [2,3]
- C1535514
Similar models
Demography
C0237753 (UMLS CUI [1,2])
C0870134 (UMLS CUI [1,2])
C0085756 (UMLS CUI [1,3])
C0870134 (UMLS CUI [1,2])
C0002460 (UMLS CUI [1,3])
C1517526 (UMLS CUI [2,1])
C0870134 (UMLS CUI [2,2])
C0682125 (UMLS CUI [2,3])
C0870134 (UMLS CUI [1,2])
C0238696 (UMLS CUI [1,3])
C1517526 (UMLS CUI [2,1])
C0870134 (UMLS CUI [2,2])
C1519427 (UMLS CUI [2,3])
C0870134 (UMLS CUI [1,2])
C4540996 (UMLS CUI [1,3])
C0870134 (UMLS CUI [1,2])
C1556094 (UMLS CUI [1,3])
C0870134 (UMLS CUI [1,2])
C0238697 (UMLS CUI [1,3])
C0870134 (UMLS CUI [1,2])
C1513907 (UMLS CUI [1,3])
C0870134 (UMLS CUI [1,2])
C1561448 (UMLS CUI [1,3])
C1517526 (UMLS CUI [2,1])
C0870134 (UMLS CUI [2,2])
C0238604 (UMLS CUI [2,3])
C0870134 (UMLS CUI [1,2])
C0043157 (UMLS CUI [1,3])
C1517526 (UMLS CUI [2,1])
C0870134 (UMLS CUI [2,2])
C1535514 (UMLS CUI [2,3])