ID

40396

Beschrijving

Study ID: 111314 Clinical Study ID: 111314 Study Title: A first-time-in-human, three-part, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00857883 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1521498 or placebo Study Indication: Obesity

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Versies (1)
  1. 18-04-20 18-04-20 -
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GlaxoSmithKline

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18 april 2020

DOI

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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883

Engels

Breakfast; Ad-Lib snack total; Cotinine Test; Energy Intake Ad-Lib snack

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Study
Beschrijving

Study

Datatype

text

Alias
UMLS CUI [1]
C2603343
Subject
Beschrijving

Subject

Datatype

text

Alias
UMLS CUI [1]
C0681850
Collected by
Beschrijving

Collected by

Datatype

text

Alias
UMLS CUI [1]
C3244127
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Study Phase
Beschrijving

Study Phase

Datatype

text

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C2603343
Session
Beschrijving

Session

Datatype

text

Alias
UMLS CUI [1]
C1883017
Breakfast
Beschrijving

Breakfast

Alias
UMLS CUI-1
C2698559
Breakfast - Physical Date
Beschrijving

Breakfast - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0011008
Breakfast - Time
Beschrijving

Breakfast - Time

Datatype

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0040223
Breakfast - Day
Beschrijving

Breakfast - Day

Datatype

text

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0439228
Breakfast - Hour
Beschrijving

Breakfast - Hour

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0439227
h
Breakfast - Min
Beschrijving

Breakfast - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0439232
min
Breakfast Start Time
Beschrijving

Breakfast Start Time

Datatype

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C2698559
Breakfast Stop Time
Beschrijving

Breakfast Stop Time

Datatype

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0444930
Ad-Lib snack total
Beschrijving

Ad-Lib snack total

Alias
UMLS CUI-1
C0453863
UMLS CUI-2
C0439810
Ad-Lib snack total - Physical Date
Beschrijving

Ad-Lib snack total - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C0453863
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0011008
Ad-Lib snack total - Time
Beschrijving

Ad-Lib snack total - Time

Datatype

time

Alias
UMLS CUI [1,1]
C0453863
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0040223
Ad-Lib snack total - Day
Beschrijving

Ad-Lib snack total - Day

Datatype

text

Alias
UMLS CUI [1,1]
C0453863
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0439228
Ad-Lib snack total - Hour
Beschrijving

Ad-Lib snack total - Hour

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C0453863
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0439227
h
Ad-Lib snack total - Min
Beschrijving

Ad-Lib snack total - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C0453863
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0439232
min
Ad-Lib snack total - Total High fat/High Sugar
Beschrijving

Ad-Lib snack total - Total High fat/High Sugar

Datatype

integer

Maateenheden
  • kcal
Alias
UMLS CUI [1,1]
C0453863
UMLS CUI [1,2]
C0439810
UMLS CUI [2,1]
C0012171
UMLS CUI [2,2]
C0205250
UMLS CUI [3,1]
C0242209
UMLS CUI [3,2]
C0205250
kcal
Ad-Lib snack total - Total High fat/Low Sugar
Beschrijving

Ad-Lib snack total - Total High fat/Low Sugar

Datatype

integer

Maateenheden
  • kcal
Alias
UMLS CUI [1,1]
C0453863
UMLS CUI [1,2]
C0439810
UMLS CUI [2,1]
C0012171
UMLS CUI [2,2]
C0205250
UMLS CUI [3,1]
C0242209
UMLS CUI [3,2]
C0205251
kcal
Ad-Lib snack total - Low fat/High Sugar
Beschrijving

Ad-Lib snack total - Low fat/High Sugar

Datatype

integer

Maateenheden
  • kcal
Alias
UMLS CUI [1,1]
C0453863
UMLS CUI [1,2]
C0439810
UMLS CUI [2,1]
C0012171
UMLS CUI [2,2]
C0205251
UMLS CUI [3,1]
C0242209
UMLS CUI [3,2]
C0205250
kcal
Ad-Lib snack total - Low fat/Low Sugar
Beschrijving

Ad-Lib snack total - Low fat/Low Sugar

Datatype

integer

Maateenheden
  • kcal
Alias
UMLS CUI [1,1]
C0453863
UMLS CUI [1,2]
C0439810
UMLS CUI [2,1]
C0012171
UMLS CUI [2,2]
C0205251
UMLS CUI [3,1]
C0242209
UMLS CUI [3,2]
C0205251
kcal
Cotinine Test
Beschrijving

Cotinine Test

Alias
UMLS CUI-1
C0202363
Cotinine Test - Physical Date
Beschrijving

Cotinine Test - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C0011008
Cotinine Test - Time
Beschrijving

Cotinine Test - Time

Datatype

time

Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C0040223
Cotinine Test - Day
Beschrijving

Cotinine Test - Day

Datatype

text

Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C0439228
Cotinine Test - Hour
Beschrijving

Cotinine Test - Hour

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C0439227
h
Cotinine Test - Min
Beschrijving

Cotinine Test - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C0439232
min
Cotinine Test - Date of Test
Beschrijving

Cotinine Test - Date of Test

Datatype

date

Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C0011008
Cotinine Test - Time of Test
Beschrijving

Cotinine Test - Time of Test

Datatype

time

Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C0040223
Cotinine Test - Result
Beschrijving

Cotinine Test - Result

Datatype

integer

Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C1274040
Energy intake ad-lib snack
Beschrijving

Energy intake ad-lib snack

Alias
UMLS CUI-1
C0006777
UMLS CUI-2
C0453863
Energy intake ad-lib snack - Physical Date
Beschrijving

Energy intake ad-lib snack - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C0006777
UMLS CUI [1,2]
C0453863
UMLS CUI [1,3]
C0011008
Energy intake ad-lib snack - Time
Beschrijving

Energy intake ad-lib snack - Time

Datatype

time

Alias
UMLS CUI [1,1]
C0006777
UMLS CUI [1,2]
C0453863
UMLS CUI [1,3]
C0011008
Energy intake ad-lib snack - Day
Beschrijving

Energy intake ad-lib snack - Day

Datatype

text

Alias
UMLS CUI [1,1]
C0006777
UMLS CUI [1,2]
C0453863
UMLS CUI [1,3]
C0439228
Energy intake ad-lib snack - Hour
Beschrijving

Energy intake ad-lib snack - Hour

Datatype

integer

Alias
UMLS CUI [1,1]
C0006777
UMLS CUI [1,2]
C0453863
UMLS CUI [1,3]
C0439227
Energy intake ad-lib snack - Min
Beschrijving

Energy intake ad-lib snack - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C0006777
UMLS CUI [1,2]
C0453863
UMLS CUI [1,3]
C0439232
min
Energy intake
Beschrijving

Energy intake

Alias
UMLS CUI-1
C0006777
Prompt
Beschrijving

Prompt

Datatype

integer

Alias
UMLS CUI [1]
C1602245
Prompt Number
Beschrijving

Prompt Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1602245
UMLS CUI [1,2]
C0237753
Food Category
Beschrijving

Food Category

Datatype

text

Alias
UMLS CUI [1,1]
C0016452
UMLS CUI [1,2]
C0683312
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Similar models

Breakfast; Ad-Lib snack total; Cotinine Test; Energy Intake Ad-Lib snack

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study
Item
Study
text
C2603343 (UMLS CUI [1])
Subject
Item
Subject
text
C0681850 (UMLS CUI [1])
Collected by
Item
Collected by
text
C3244127 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Study Phase
Item
Study Phase
text
C0205390 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Session
Item
Session
text
C1883017 (UMLS CUI [1])
Item Group
Breakfast
C2698559 (UMLS CUI-1)
Breakfast - Physical Date
Item
Breakfast - Physical Date
date
C2698559 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Breakfast - Time
Item
Breakfast - Time
time
C2698559 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Breakfast - Day
Item
Breakfast - Day
text
C2698559 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Breakfast - Hour
Item
Breakfast - Hour
integer
C2698559 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Breakfast - Min
Item
Breakfast - Min
integer
C2698559 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Breakfast Start Time
Item
Breakfast Start Time
time
C1301880 (UMLS CUI [1,1])
C2698559 (UMLS CUI [1,2])
Breakfast Stop Time
Item
Breakfast Stop Time
time
C2698559 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
Item Group
Ad-Lib snack total
C0453863 (UMLS CUI-1)
C0439810 (UMLS CUI-2)
Ad-Lib snack total - Physical Date
Item
Ad-Lib snack total - Physical Date
date
C0453863 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Ad-Lib snack total - Time
Item
Ad-Lib snack total - Time
time
C0453863 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Ad-Lib snack total - Day
Item
Ad-Lib snack total - Day
text
C0453863 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Ad-Lib snack total - Hour
Item
Ad-Lib snack total - Hour
integer
C0453863 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Ad-Lib snack total - Min
Item
Ad-Lib snack total - Min
integer
C0453863 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Ad-Lib snack total - Total High fat/High Sugar
Item
Ad-Lib snack total - Total High fat/High Sugar
integer
C0453863 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0012171 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C0242209 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
Ad-Lib snack total - Total High fat/Low Sugar
Item
Ad-Lib snack total - Total High fat/Low Sugar
integer
C0453863 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0012171 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C0242209 (UMLS CUI [3,1])
C0205251 (UMLS CUI [3,2])
Ad-Lib snack total - Low fat/High Sugar
Item
Ad-Lib snack total - Low fat/High Sugar
integer
C0453863 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0012171 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0242209 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
Ad-Lib snack total - Low fat/Low Sugar
Item
Ad-Lib snack total - Low fat/Low Sugar
integer
C0453863 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0012171 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0242209 (UMLS CUI [3,1])
C0205251 (UMLS CUI [3,2])
Item Group
Cotinine Test
C0202363 (UMLS CUI-1)
Cotinine Test - Physical Date
Item
Cotinine Test - Physical Date
date
C0202363 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Cotinine Test - Time
Item
Cotinine Test - Time
time
C0202363 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Cotinine Test - Day
Item
Cotinine Test - Day
text
C0202363 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Cotinine Test - Hour
Item
Cotinine Test - Hour
integer
C0202363 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Cotinine Test - Min
Item
Cotinine Test - Min
integer
C0202363 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Cotinine Test - Date of Test
Item
Cotinine Test - Date of Test
date
C0202363 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Cotinine Test - Time of Test
Item
Cotinine Test - Time of Test
time
C0202363 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Cotinine Test - Result
integer
C0202363 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Cotinine Test - Result
Code List
Cotinine Test - Result
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Energy intake ad-lib snack
C0006777 (UMLS CUI-1)
C0453863 (UMLS CUI-2)
Energy intake ad-lib snack - Physical Date
Item
Energy intake ad-lib snack - Physical Date
date
C0006777 (UMLS CUI [1,1])
C0453863 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Energy intake ad-lib snack - Time
Item
Energy intake ad-lib snack - Time
time
C0006777 (UMLS CUI [1,1])
C0453863 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Energy intake ad-lib snack - Day
Item
Energy intake ad-lib snack - Day
text
C0006777 (UMLS CUI [1,1])
C0453863 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Energy intake ad-lib snack - Hour
Item
Energy intake ad-lib snack - Hour
integer
C0006777 (UMLS CUI [1,1])
C0453863 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Energy intake ad-lib snack - Min
Item
Energy intake ad-lib snack - Min
integer
C0006777 (UMLS CUI [1,1])
C0453863 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Item Group
Energy intake
C0006777 (UMLS CUI-1)
Item
Prompt
integer
C1602245 (UMLS CUI [1])
Prompt
Code List
Prompt
CL Item
Snickers Bar (1)
CL Item
M & M’s (2)
CL Item
Oreo Cookies (3)
CL Item
Doritos (4)
CL Item
Ritz Crackers with Cream Cheese (5)
CL Item
Shortbread (6)
CL Item
Crisps (7)
CL Item
Jelly Beans (8)
CL Item
Marshmallows (9)
CL Item
Strawberry Jelly (10)
CL Item
Jam Sandwich (11)
CL Item
Popcorn (12)
CL Item
Water Biscuits (13)
CL Item
Breadsticks (14)
CL Item
Pretzels (15)
CL Item
Choc-chip cookies  (16)
Prompt Number
Item
Prompt Number
integer
C1602245 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Food Category
text
C0016452 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Food Category
Code List
Food Category
CL Item
Low Fat/High Sugar (LFHS)
CL Item
High Fat/ Low Sugar (HFLS)
CL Item
High Fat/High Sugar (HFHS)
CL Item
Low Fat/Low Sugar (LFLS)
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