ID
38074
Beschreibung
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.
Stichworte
Versionen (1)
- 15.09.19 15.09.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
15. September 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Darapladib Evaluation Case Report Form GSK LPL107988
Laboratory Results
Beschreibung
Liver Events Assessment
Alias
- UMLS CUI-1
- C0023901
- UMLS CUI-2
- C0441471
Beschreibung
If Yes, stop investigational product, complete date stopped on Investigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following tests: • PK blood sample within 24 hours of last dose (or 3x the investigational product half-life or t1/2) • Hepatitis A: Hepatitis A lgM antibody. • Hepatitis B: Hepatitis B surface antigen and Hepatitis B Core Antibody (lgM). • Hepatitis C: Hepatitis C RNA. • Hepatitis E IgM antibody (if subject resides or has travelled in past 3 months outside the USA or Canada). • Cytomegalovirus IgM antibody (CMV) • EBV (Epstein Barr viral capsid antigen IgM antibody) or if unavailable, obtain heterophile antibody or monospot testing. • CPK (serum creatine phosphokinase) • LDH (lactate dehydrogenase) • Bilirubin fractionation, if bilirubin >1.5xULN
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0023901
- UMLS CUI [1,2]
- C0439093
- UMLS CUI [1,3]
- C2348563
- UMLS CUI [1,4]
- C2746065
- UMLS CUI [1,5]
- C0243161
- UMLS CUI [2]
- C0001899
- UMLS CUI [3]
- C0004002
- UMLS CUI [4]
- C0002059
- UMLS CUI [5]
- C0368753
- UMLS CUI [6]
- C0017040
Beschreibung
Pharmacokinetics Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Beschreibung
Date and actual time sample taken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1277698
- UMLS CUI [2,1]
- C0237400
- UMLS CUI [2,2]
- C0040223
- UMLS CUI [2,3]
- C1277698
Beschreibung
Please fill out this item for every timepoint to match the actual time with the planned relative time.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1301732
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C1277698
- UMLS CUI [2,1]
- C1301732
- UMLS CUI [2,2]
- C0040223
- UMLS CUI [2,3]
- C1277698
Beschreibung
Pharmacodynamics Blood
Alias
- UMLS CUI-1
- C0243145
- UMLS CUI-2
- C0005767
Beschreibung
Date and actual time sample taken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1277698
- UMLS CUI [2,1]
- C0237400
- UMLS CUI [2,2]
- C0040223
- UMLS CUI [2,3]
- C1277698
Beschreibung
Please fill out this item for every timepoint to match the actual time with the planned relative time.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1301732
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C1277698
- UMLS CUI [2,1]
- C1301732
- UMLS CUI [2,2]
- C0040223
- UMLS CUI [2,3]
- C1277698
Ähnliche Modelle
Laboratory Results
C0441471 (UMLS CUI-2)
C0439093 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
C0243161 (UMLS CUI [1,5])
C0001899 (UMLS CUI [2])
C0004002 (UMLS CUI [3])
C0002059 (UMLS CUI [4])
C0368753 (UMLS CUI [5])
C0017040 (UMLS CUI [6])
C0005767 (UMLS CUI-2)
C1277698 (UMLS CUI [1,2])
C0237400 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1277698 (UMLS CUI [2,3])
C0011008 (UMLS CUI [1,2])
C1277698 (UMLS CUI [1,3])
C1301732 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1277698 (UMLS CUI [2,3])
C0005767 (UMLS CUI-2)
C1277698 (UMLS CUI [1,2])
C0237400 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1277698 (UMLS CUI [2,3])
C0011008 (UMLS CUI [1,2])
C1277698 (UMLS CUI [1,3])
C1301732 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1277698 (UMLS CUI [2,3])