ID

40973

Beskrivning

The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitus Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

Nyckelord

Versioner (2)
  1. 2020-06-07 2020-06-07 -
  2. 2020-06-07 2020-06-07 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

7 juni 2020

DOI

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Licens

Creative Commons BY-NC 4.0
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A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin

Engelsk

Vital Signs V2 5-DF

1 Formulär  
  1. StudyEvent: ODM
    1. Vital Signs V2 5-DF
Dosing Date and Time
Beskrivning

Dosing Date and Time

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing date/time
Beskrivning

Item is not required

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Predose 1
Beskrivning

Predose 1

Alias
UMLS CUI-1
C0439565
Actual time
Beskrivning

Actual time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Predose 2
Beskrivning

Predose 2

Alias
UMLS CUI-1
C0439565
Actual time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Predose 3
Beskrivning

Predose 3

Alias
UMLS CUI-1
C0439565
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Actual time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
1 Hour
Beskrivning

1 Hour

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0439568
UMLS CUI-3
C0439227
Actual time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
3 Hours
Beskrivning

3 Hours

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0439568
UMLS CUI-3
C0439227
Actual time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
4 Hours
Beskrivning

4 Hours

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0439568
UMLS CUI-3
C0439227
Actual time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
8 Hours
Beskrivning

8 Hours

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0439568
UMLS CUI-3
C0439227
Actual time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
12 Hours
Beskrivning

12 Hours

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0439568
UMLS CUI-3
C0439227
Actual time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
16 Hours
Beskrivning

16 Hours

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0439568
UMLS CUI-3
C0439227
Actual time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
24 Hours
Beskrivning

24 Hours

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0439568
UMLS CUI-3
C0439227
Actual time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Tillbaka till toppen

Similar models

Vital Signs V2 5-DF

1 Formulär
  1. StudyEvent: ODM
    1. Vital Signs V2 5-DF
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Dosing Date and Time
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Dosing date/time
Item
Dosing date/time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Predose 1
C0439565 (UMLS CUI-1)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (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])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Predose 2
C0439565 (UMLS CUI-1)
Actual Time
Item
Actual time
time
C0040223 (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])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Predose 3
C0439565 (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])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Item Group
1 Hour
C0040223 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
Actual Time
Item
Actual time
time
C0040223 (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])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
3 Hours
C0040223 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
Actual Time
Item
Actual time
time
C0040223 (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])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
4 Hours
C0040223 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
Actual Time
Item
Actual time
time
C0040223 (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])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
8 Hours
C0040223 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
Actual Time
Item
Actual time
time
C0040223 (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])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
12 Hours
C0040223 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
Actual Time
Item
Actual time
time
C0040223 (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])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
16 Hours
C0040223 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
Actual Time
Item
Actual time
time
C0040223 (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])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
24 Hours
C0040223 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
Actual Time
Item
Actual time
time
C0040223 (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])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Tillbaka till toppen 

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