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)
  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

Englisch

Laboratory Results

12 Formulare  
Administrative documentation
Beschreibung

Administrative documentation

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Liver Events Assessment
Beschreibung

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?
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
Pharmacokinetics Blood
Beschreibung

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Date and actual time sample taken
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
Planned relative time
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
Pharmacodynamics Blood
Beschreibung

Pharmacodynamics Blood

Alias
UMLS CUI-1
C0243145
UMLS CUI-2
C0005767
Date and actual time sample taken
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
Planned relative time
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
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Ähnliche Modelle

Laboratory Results

12 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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