ID

40988

Description

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 Mellitis 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

Keywords

  1. 6/7/20 6/7/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 7, 2020

DOI

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License

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

Pharmacodynamics - (mOGTT - Blood) V8 9-DF

Glucose admin date and time
Description

Glucose admin date and time

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0808070
UMLS CUI-3
C1301880
UMLS CUI-4
C0017725
Time of glucose administration
Description

Time of glucose administration

Data type

datetime

Alias
UMLS CUI [1,1]
C1317775
UMLS CUI [1,2]
C0017725
10 minutes pre-glucose
Description

10 minutes pre-glucose

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0200345
UMLS CUI-3
C0017725
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Pre-glucose
Description

Pre-glucose

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0200345
UMLS CUI-3
C0017725
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
10 minutes post
Description

10 minutes post

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0200345
UMLS CUI-3
C0017725
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
20 minutes post
Description

20 minutes post

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0200345
UMLS CUI-3
C0017725
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
30 minutes post
Description

30 minutes post

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0200345
UMLS CUI-3
C0017725
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
60 minutes post
Description

60 minutes post

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0200345
UMLS CUI-3
C0017725
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
90 minutes post
Description

90 minutes post

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0200345
UMLS CUI-3
C0017725
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
120 minutes post
Description

120 minutes post

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0200345
UMLS CUI-3
C0017725
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
180 minutes post
Description

180 minutes post

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0200345
UMLS CUI-3
C0017725
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345

Similar models

Pharmacodynamics - (mOGTT - Blood) V8 9-DF

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Glucose admin date and time
C0013227 (UMLS CUI-1)
C0808070 (UMLS CUI-2)
C1301880 (UMLS CUI-3)
C0017725 (UMLS CUI-4)
Time of glucose administration
Item
Time of glucose administration
datetime
C1317775 (UMLS CUI [1,1])
C0017725 (UMLS CUI [1,2])
Item Group
10 minutes pre-glucose
C0040223 (UMLS CUI-1)
C0200345 (UMLS CUI-2)
C0017725 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
Pre-glucose
C0040223 (UMLS CUI-1)
C0200345 (UMLS CUI-2)
C0017725 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
10 minutes post
C0040223 (UMLS CUI-1)
C0200345 (UMLS CUI-2)
C0017725 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
20 minutes post
C0040223 (UMLS CUI-1)
C0200345 (UMLS CUI-2)
C0017725 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
30 minutes post
C0040223 (UMLS CUI-1)
C0200345 (UMLS CUI-2)
C0017725 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
60 minutes post
C0040223 (UMLS CUI-1)
C0200345 (UMLS CUI-2)
C0017725 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
90 minutes post
C0040223 (UMLS CUI-1)
C0200345 (UMLS CUI-2)
C0017725 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
120 minutes post
C0040223 (UMLS CUI-1)
C0200345 (UMLS CUI-2)
C0017725 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
180 minutes post
C0040223 (UMLS CUI-1)
C0200345 (UMLS CUI-2)
C0017725 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])

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