ID

38074

Description

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.

Keywords

Versions (1)
  1. 9/15/19 9/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Darapladib Evaluation Case Report Form GSK LPL107988

English

Laboratory Results

12 forms  
Administrative documentation
Description

Administrative documentation

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Liver Events Assessment
Description

Liver Events Assessment

Alias
UMLS CUI-1
C0023901
UMLS CUI-2
C0441471
Have liver chemistry (ALT, AST, alkaline phosphatase, total bilirubin, or Gammaglutamyltranspeptidase) results reached or exceeded protocol-defined investigational product stopping criteria?
Description

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

Data type

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
Pharmacokinetics Blood
Description

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Date and actual time sample taken
Description

Date and actual time sample taken

Data type

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
Planned relative time
Description

Please fill out this item for every timepoint to match the actual time with the planned relative time.

Data type

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
Pharmacodynamics Blood
Description

Pharmacodynamics Blood

Alias
UMLS CUI-1
C0243145
UMLS CUI-2
C0005767
Date and actual time sample taken
Description

Date and actual time sample taken

Data type

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
Planned relative time
Description

Please fill out this item for every timepoint to match the actual time with the planned relative time.

Data type

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
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Similar models

Laboratory Results

12 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative documentation
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Liver Events Assessment
C0023901 (UMLS CUI-1)
C0441471 (UMLS CUI-2)
Liver chemistry results
Item
Have liver chemistry (ALT, AST, alkaline phosphatase, total bilirubin, or Gammaglutamyltranspeptidase) results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0023901 (UMLS CUI [1,1])
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])
Item Group
Pharmacokinetics Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Date and actual time sample taken
Item
Date and actual time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
C0237400 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1277698 (UMLS CUI [2,3])
Item
Planned relative time
integer
C1301732 (UMLS CUI [1,1])
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])
Planned relative time
Code List
Planned relative time
CL Item
Predose (1)
CL Item
0.5hr (2)
CL Item
1hr (3)
CL Item
2hr (4)
CL Item
3hr (5)
CL Item
4hr (6)
CL Item
6hr (7)
CL Item
9hr (8)
CL Item
12hr (9)
CL Item
18hr (10)
CL Item
24hr (11)
CL Item
32hr (12)
CL Item
48hr (13)
CL Item
72hr (14)
CL Item
96hr (15)
Item Group
Pharmacodynamics Blood
C0243145 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Date and actual time sample taken
Item
Date and actual time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
C0237400 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1277698 (UMLS CUI [2,3])
Item
Planned relative time
integer
C1301732 (UMLS CUI [1,1])
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])
undefined item
Code List
Planned relative time
CL Item
Predose (1)
CL Item
0.5hr (2)
CL Item
1hr (3)
CL Item
2hr (4)
CL Item
3hr (5)
CL Item
4hr (6)
CL Item
6hr (7)
CL Item
9hr (8)
CL Item
12hr (9)
CL Item
18hr (10)
CL Item
24hr (11)
CL Item
32hr (12)
CL Item
48hr (13)
CL Item
72hr (14)
CL Item
96hr (15)
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