ID

40897

Descripción

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

Palabras clave

Versiones (3)
  1. 31/5/20 31/5/20 -
  2. 31/5/20 31/5/20 -
  3. 7/6/20 7/6/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

31 de mayo de 2020

DOI

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Licencia

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

Inglés

Vital Signs (VS-contd)

1 formularios  
  1. StudyEvent: ODM
    1. Vital Signs (VS-contd)
Dosing Date and Time
Descripción

Dosing Date and Time

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

Item is not required

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
30 Hours
Descripción

30 Hours

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0439568
UMLS CUI-3
C0439227
Systolic blood pressure
Descripción

Systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Actual time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
36 Hours
Descripción

36 Hours

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0439568
UMLS CUI-3
C0439227
Systolic blood pressure
Descripción

Systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Actual time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
42 Hours
Descripción

42 Hours

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0439568
UMLS CUI-3
C0439227
Systolic blood pressure
Descripción

Systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Actual time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
72 Hours
Descripción

72 Hours

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0439568
UMLS CUI-3
C0439227
Systolic blood pressure
Descripción

Systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Actual time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
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Similar models

Vital Signs (VS-contd)

1 formularios
  1. StudyEvent: ODM
    1. Vital Signs (VS-contd)
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
30 Hours
C0040223 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
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
36 Hours
C0040223 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
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
42 Hours
C0040223 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
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
72 Hours
C0040223 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
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])
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