ID

40396

Description

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

Mots-clés

Versions (1)
  1. 18/04/2020 18/04/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

18 avril 2020

DOI

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Licence

Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883

Anglais

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

1 Formulaires  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Study
Description

Study

Type de données

text

Alias
UMLS CUI [1]
C2603343
Subject
Description

Subject

Type de données

text

Alias
UMLS CUI [1]
C0681850
Collected by
Description

Collected by

Type de données

text

Alias
UMLS CUI [1]
C3244127
Subject Number
Description

Subject Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Study Phase
Description

Study Phase

Type de données

text

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

Session

Type de données

text

Alias
UMLS CUI [1]
C1883017
Breakfast
Description

Breakfast

Alias
UMLS CUI-1
C2698559
Breakfast - Physical Date
Description

Breakfast - Physical Date

Type de données

date

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

Breakfast - Time

Type de données

time

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

Breakfast - Day

Type de données

text

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

Breakfast - Hour

Type de données

integer

Unités de mesure
  • h
Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0439227
h
Breakfast - Min
Description

Breakfast - Min

Type de données

integer

Unités de mesure
  • min
Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0439232
min
Breakfast Start Time
Description

Breakfast Start Time

Type de données

time

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

Breakfast Stop Time

Type de données

time

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

Ad-Lib snack total

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

Ad-Lib snack total - Physical Date

Type de données

date

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

Ad-Lib snack total - Time

Type de données

time

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

Ad-Lib snack total - Day

Type de données

text

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

Ad-Lib snack total - Hour

Type de données

integer

Unités de mesure
  • h
Alias
UMLS CUI [1,1]
C0453863
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0439227
h
Ad-Lib snack total - Min
Description

Ad-Lib snack total - Min

Type de données

integer

Unités de mesure
  • 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
Description

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

Type de données

integer

Unités de mesure
  • 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
Description

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

Type de données

integer

Unités de mesure
  • 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
Description

Ad-Lib snack total - Low fat/High Sugar

Type de données

integer

Unités de mesure
  • 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
Description

Ad-Lib snack total - Low fat/Low Sugar

Type de données

integer

Unités de mesure
  • 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
Description

Cotinine Test

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

Cotinine Test - Physical Date

Type de données

date

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

Cotinine Test - Time

Type de données

time

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

Cotinine Test - Day

Type de données

text

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

Cotinine Test - Hour

Type de données

integer

Unités de mesure
  • h
Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C0439227
h
Cotinine Test - Min
Description

Cotinine Test - Min

Type de données

integer

Unités de mesure
  • min
Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C0439232
min
Cotinine Test - Date of Test
Description

Cotinine Test - Date of Test

Type de données

date

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

Cotinine Test - Time of Test

Type de données

time

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

Cotinine Test - Result

Type de données

integer

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

Energy intake ad-lib snack

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

Energy intake ad-lib snack - Physical Date

Type de données

date

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

Energy intake ad-lib snack - Time

Type de données

time

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

Energy intake ad-lib snack - Day

Type de données

text

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

Energy intake ad-lib snack - Hour

Type de données

integer

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

Energy intake ad-lib snack - Min

Type de données

integer

Unités de mesure
  • min
Alias
UMLS CUI [1,1]
C0006777
UMLS CUI [1,2]
C0453863
UMLS CUI [1,3]
C0439232
min
Energy intake
Description

Energy intake

Alias
UMLS CUI-1
C0006777
Prompt
Description

Prompt

Type de données

integer

Alias
UMLS CUI [1]
C1602245
Prompt Number
Description

Prompt Number

Type de données

integer

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

Food Category

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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