ID

41632

Description

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Keywords

Versions (2)
  1. 11/11/20 11/11/20 -
  2. 11/29/20 11/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 29, 2020

DOI

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License

Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

English

Day 1 - 5: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection (Simvastatin)

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Subject
Description

Subject

Data type

text

Alias
UMLS CUI [1]
C2348585
Status
Description

Status

Data type

text

Alias
UMLS CUI [1]
C0449438
Doc#
Description

Doc#

Data type

integer

Alias
UMLS CUI [1]
C1301746
Is Page Blank?
Description

Is Page Blank?

Data type

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0750479
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Vital Signs (sitting) - Day 1 - 5
Description

Vital Signs (sitting) - Day 1 - 5

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0277814
Vital Signs Date
Description

Vital Signs Date

Data type

date

Alias
UMLS CUI [1]
C2826644
Vital Signs Time
Description

Vital Signs Time

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Study Drug Administration (80 mg Simvastatin) - Day 1
Description

Study Drug Administration (80 mg Simvastatin) - Day 1

Alias
UMLS CUI-1
C0013153
UMLS CUI-2
C0074554
Was the dose administered?
Description

Was the dose administered?

Data type

boolean

Alias
UMLS CUI [1]
C3174092
UMLS CUI [2]
C3469597
Dose Date
Description

Dose Date

Data type

date

Alias
UMLS CUI [1]
C0178602
UMLS CUI [2]
C0011008
Dose Time
Description

Dose Time

Data type

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Pharmacokinetic Blood Collection (Simvastatin) - Day 1
Description

Pharmacokinetic Blood Collection (Simvastatin) - Day 1

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005834
UMLS CUI-3
C0074554
Timepoint
Description

Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
Sample Date
Description

Sample Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Sample Time
Description

Sample Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Not Done/ Not Collected
Description

Not Done/ Not Collected

Data type

integer

Alias
UMLS CUI [1]
C1272696
UMLS CUI [2]
C0445106
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Pharmacokinetic Blood Collection (Simvastatin) - Day 2
Description

Pharmacokinetic Blood Collection (Simvastatin) - Day 2

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005834
UMLS CUI-3
C0074554
Timepoint
Description

Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
Sample Date
Description

Sample Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Sample Time
Description

Sample Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Not Done/ Not Collected
Description

Not Done/ Not Collected

Data type

integer

Alias
UMLS CUI [1]
C1272696
UMLS CUI [2]
C0445106
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Pharmacokinetic Blood Collection (Simvastatin) - Day 3
Description

Pharmacokinetic Blood Collection (Simvastatin) - Day 3

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005834
UMLS CUI-3
C0074554
Timepoint
Description

Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
Sample Date
Description

Sample Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Sample Time
Description

Sample Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Not Done/ Not Collected
Description

Not Done/ Not Collected

Data type

integer

Alias
UMLS CUI [1]
C1272696
UMLS CUI [2]
C0445106
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Pharmacokinetic Blood Collection (Simvastatin) - Day 4
Description

Pharmacokinetic Blood Collection (Simvastatin) - Day 4

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005834
UMLS CUI-3
C0074554
Timepoint
Description

Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
Sample Date
Description

Sample Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Sample Time
Description

Sample Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Not Done/ Not Collected
Description

Not Done/ Not Collected

Data type

integer

Alias
UMLS CUI [1]
C1272696
UMLS CUI [2]
C0445106
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Pharmacokinetic Blood Collection (Simvastatin) - Day 5
Description

Pharmacokinetic Blood Collection (Simvastatin) - Day 5

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005834
UMLS CUI-3
C0074554
Timepoint
Description

Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
Sample Date
Description

Sample Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Sample Time
Description

Sample Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Not Done/ Not Collected
Description

Not Done/ Not Collected

Data type

integer

Alias
UMLS CUI [1]
C1272696
UMLS CUI [2]
C0445106
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Day 1 - 5: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection (Simvastatin)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Subject
Item
Subject
text
C2348585 (UMLS CUI [1])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Doc#
Item
Doc#
integer
C1301746 (UMLS CUI [1])
Is Page Blank?
Item
Is Page Blank?
boolean
C1704732 (UMLS CUI [1,1])
C0750479 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs (sitting) - Day 1 - 5
C0518766 (UMLS CUI-1)
C0277814 (UMLS CUI-2)
Vital Signs Date
Item
Vital Signs Date
date
C2826644 (UMLS CUI [1])
Vital Signs Time
Item
Vital Signs Time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Study Drug Administration (80 mg Simvastatin) - Day 1
C0013153 (UMLS CUI-1)
C0074554 (UMLS CUI-2)
Was the dose administered?
Item
Was the dose administered?
boolean
C3174092 (UMLS CUI [1])
C3469597 (UMLS CUI [2])
Dose Date
Item
Dose Date
date
C0178602 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Dose Time
Item
Dose Time
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Pharmacokinetic Blood Collection (Simvastatin) - Day 1
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
Predose (1)
CL Item
0.25 hr (2)
CL Item
0.5 hr (3)
CL Item
1 hr (4)
CL Item
1.5 hr (5)
CL Item
2 hr (6)
CL Item
2.5 hr (7)
CL Item
3 hr (8)
CL Item
4 hr (9)
CL Item
5 hr (10)
CL Item
6 hr (11)
CL Item
8 hr (12)
CL Item
10 hr (13)
CL Item
12 hr (14)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Not Done/ Not Collected
integer
C1272696 (UMLS CUI [1])
C0445106 (UMLS CUI [2])
Not Done/ Not Collected
Code List
Not Done/ Not Collected
CL Item
Not Done/ Not Collected (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Pharmacokinetic Blood Collection (Simvastatin) - Day 2
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
24 hr (1)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Not Done/ Not Collected
integer
C1272696 (UMLS CUI [1])
C0445106 (UMLS CUI [2])
Not Done/ Not Collected
Code List
Not Done/ Not Collected
CL Item
Not Done/ Not Collected (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Pharmacokinetic Blood Collection (Simvastatin) - Day 3
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
48 hr (1)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Not Done/ Not Collected
integer
C1272696 (UMLS CUI [1])
C0445106 (UMLS CUI [2])
Not Done/ Not Collected
Code List
Not Done/ Not Collected
CL Item
Not Done/ Not Collected (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Pharmacokinetic Blood Collection (Simvastatin) - Day 4
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
72 hr (1)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Not Done/ Not Collected
integer
C1272696 (UMLS CUI [1])
C0445106 (UMLS CUI [2])
Not Done/ Not Collected
Code List
Not Done/ Not Collected
CL Item
Not Done/ Not Collected (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Pharmacokinetic Blood Collection (Simvastatin) - Day 5
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
96 hr (1)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Not Done/ Not Collected
integer
C1272696 (UMLS CUI [1])
C0445106 (UMLS CUI [2])
Not Done/ Not Collected
Code List
Not Done/ Not Collected
CL Item
Not Done/ Not Collected (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
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