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

Investigational Product

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
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C3897779
UMLS CUI-2
C0237753
Randomisation Number
Description

Randomisation Number

Data type

integer

Alias
UMLS CUI [1,1]
C3897779
UMLS CUI [1,2]
C0237753
Date of Randomisation
Description

Date of Randomisation

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Investigational Product Exposure
Description

Investigational Product Exposure

Alias
UMLS CUI-1
C0332157
UMLS CUI-2
C4688482
Investigational Product
Description

73 = Placebo 198 = SB-480848 (Darapladib)

Data type

integer

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C4688482
Date and Time of Dose
Description

Date and Time of Dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0178602
Dose
Description

Dose

Data type

integer

Alias
UMLS CUI [1]
C0178602
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C0869039
Treatment Confirmation
Description

Treatment Confirmation

Alias
UMLS CUI-1
C0521091
UMLS CUI-2
C1533734
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

If No, record reason(s)

Data type

boolean

Alias
UMLS CUI [1,1]
C0521091
UMLS CUI [1,2]
C1533734
No Correct Treatment reasons
Description

No Correct Treatment reasons

Data type

text

Alias
UMLS CUI [1,1]
C1272707
UMLS CUI [1,2]
C0205412
UMLS CUI [1,3]
C0087111
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Similar models

Investigational Product

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
Randomisation Number
C3897779 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation Number
Item
Randomisation Number
integer
C3897779 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of Randomisation
Item
Date of Randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Investigational Product Exposure
C0332157 (UMLS CUI-1)
C4688482 (UMLS CUI-2)
Investigational Product
Item
Investigational Product
integer
C0332157 (UMLS CUI [1,1])
C4688482 (UMLS CUI [1,2])
Date and Time of Dose
Item
Date and Time of Dose
datetime
C0011008 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Dose
Item
Dose
integer
C0178602 (UMLS CUI [1])
Unit
Item
Unit
text
C0869039 (UMLS CUI [1])
Item Group
Treatment Confirmation
C0521091 (UMLS CUI-1)
C1533734 (UMLS CUI-2)
Treatment Confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0521091 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
No Correct Treatment reasons
Item
No Correct Treatment reasons
text
C1272707 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
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