ID

40954

Beschreibung

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

Stichworte

Versionen (2)
  1. 25.04.20 25.04.20 -
  2. 07.06.20 07.06.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

7. Juni 2020

DOI

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Lizenz

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

Englisch

Pharmacokinetics (Liver PK), Liver Event 4-DF

1 Formulare  
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).
Beschreibung

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?
Beschreibung

pharmacokinetic blood sample

Datentyp

boolean

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

date blood sample taken

Datentyp

date

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

time blood sample taken

Datentyp

time

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

date last investigational product dose prior to PK sample

Datentyp

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
Beschreibung

time last investigational product dose prior to PK sample

Datentyp

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
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C1299222
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Ähnliche Modelle

Pharmacokinetics (Liver PK), Liver Event 4-DF

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