ID

40954

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 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

Keywords

Versions (2)
  1. 4/25/20 4/25/20 -
  2. 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

English

Pharmacokinetics (Liver PK), Liver Event 4-DF

1 forms  
An unscheduled PK blood sample must be obtained within 24 hours of last dose (or 3x the investigational product half-life or t1/2; protocol specified longer value to be inserted).
Description

An unscheduled PK blood sample must be obtained within 24 hours of last dose (or 3x the investigational product half-life or t1/2; protocol specified longer value to be inserted).

Alias
UMLS CUI-1
C3854240
UMLS CUI-2
C0031327
UMLS CUI-3
C0005834
UMLS CUI-4
C3843067
UMLS CUI-5
C0946444
UMLS CUI-6
C0013230
1. Was a pharmacokinetic blood sample obtained?
Description

pharmacokinetic blood sample

Data type

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005834
If yes, date sample taken
Description

date blood sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
If yes, time sample taken
Description

time blood sample taken

Data type

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
If Yes, date of last investigational product dose prior to PK sample
Description

date last investigational product dose prior to PK sample

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0678766
UMLS CUI [1,4]
C0013230
UMLS CUI [1,5]
C0332152
UMLS CUI [1,6]
C0031328
UMLS CUI [1,7]
C0178913
If Yes, time of last investigational product dose prior to PK sample
Description

time last investigational product dose prior to PK sample

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0678766
UMLS CUI [1,4]
C0013230
UMLS CUI [1,5]
C0332152
UMLS CUI [1,6]
C0031328
UMLS CUI [1,7]
C0178913
Sample Identifier/Sample Number
Description

Sample Identifier and Sample Number are conditional. The study team must choose one for inclusion on the eCRF form.

Data type

integer

Alias
UMLS CUI [1]
C1299222
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Similar models

Pharmacokinetics (Liver PK), Liver Event 4-DF

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
An unscheduled PK blood sample must be obtained within 24 hours of last dose (or 3x the investigational product half-life or t1/2; protocol specified longer value to be inserted).
C3854240 (UMLS CUI-1)
C0031327 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
C3843067 (UMLS CUI-4)
C0946444 (UMLS CUI-5)
C0013230 (UMLS CUI-6)
pharmacokinetic blood sample
Item
1. Was a pharmacokinetic blood sample obtained?
boolean
C0031328 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
date blood sample taken
Item
If yes, date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
time blood sample taken
Item
If yes, time sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
date last investigational product dose prior to PK sample
Item
If Yes, date of last investigational product dose prior to PK sample
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0332152 (UMLS CUI [1,5])
C0031328 (UMLS CUI [1,6])
C0178913 (UMLS CUI [1,7])
time last investigational product dose prior to PK sample
Item
If Yes, time of last investigational product dose prior to PK sample
time
C0040223 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0332152 (UMLS CUI [1,5])
C0031328 (UMLS CUI [1,6])
C0178913 (UMLS CUI [1,7])
Sample Identifier/Sample Number
Item
Sample Identifier/Sample Number
integer
C1299222 (UMLS CUI [1])
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