ID

40396

Beschreibung

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

Stichworte

Versionen (1)
  1. 18.04.20 18.04.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

18. April 2020

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Study
Beschreibung

Study

Datentyp

text

Alias
UMLS CUI [1]
C2603343
Subject
Beschreibung

Subject

Datentyp

text

Alias
UMLS CUI [1]
C0681850
Collected by
Beschreibung

Collected by

Datentyp

text

Alias
UMLS CUI [1]
C3244127
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Study Phase
Beschreibung

Study Phase

Datentyp

text

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

Session

Datentyp

text

Alias
UMLS CUI [1]
C1883017
Breakfast
Beschreibung

Breakfast

Alias
UMLS CUI-1
C2698559
Breakfast - Physical Date
Beschreibung

Breakfast - Physical Date

Datentyp

date

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

Breakfast - Time

Datentyp

time

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

Breakfast - Day

Datentyp

text

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

Breakfast - Hour

Datentyp

integer

Maßeinheiten
  • h
Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0439227
h
Breakfast - Min
Beschreibung

Breakfast - Min

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0439232
min
Breakfast Start Time
Beschreibung

Breakfast Start Time

Datentyp

time

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

Breakfast Stop Time

Datentyp

time

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

Ad-Lib snack total

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

Ad-Lib snack total - Physical Date

Datentyp

date

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

Ad-Lib snack total - Time

Datentyp

time

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

Ad-Lib snack total - Day

Datentyp

text

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

Ad-Lib snack total - Hour

Datentyp

integer

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

Ad-Lib snack total - Min

Datentyp

integer

Maßeinheiten
  • 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
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • 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
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • 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
Beschreibung

Ad-Lib snack total - Low fat/High Sugar

Datentyp

integer

Maßeinheiten
  • 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
Beschreibung

Ad-Lib snack total - Low fat/Low Sugar

Datentyp

integer

Maßeinheiten
  • 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
Beschreibung

Cotinine Test

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

Cotinine Test - Physical Date

Datentyp

date

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

Cotinine Test - Time

Datentyp

time

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

Cotinine Test - Day

Datentyp

text

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

Cotinine Test - Hour

Datentyp

integer

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

Cotinine Test - Min

Datentyp

integer

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

Cotinine Test - Date of Test

Datentyp

date

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

Cotinine Test - Time of Test

Datentyp

time

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

Cotinine Test - Result

Datentyp

integer

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

Energy intake ad-lib snack

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

Energy intake ad-lib snack - Physical Date

Datentyp

date

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

Energy intake ad-lib snack - Time

Datentyp

time

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

Energy intake ad-lib snack - Day

Datentyp

text

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

Energy intake ad-lib snack - Hour

Datentyp

integer

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

Energy intake ad-lib snack - Min

Datentyp

integer

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

Energy intake

Alias
UMLS CUI-1
C0006777
Prompt
Beschreibung

Prompt

Datentyp

integer

Alias
UMLS CUI [1]
C1602245
Prompt Number
Beschreibung

Prompt Number

Datentyp

integer

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

Food Category

Datentyp

text

Alias
UMLS CUI [1,1]
C0016452
UMLS CUI [1,2]
C0683312
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Ähnliche Modelle

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

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