ID

40941

Beschrijving

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

Trefwoorden

  1. 19-04-20 19-04-20 -
  2. 07-06-20 07-06-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

7 juni 2020

DOI

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Licentie

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

Status of treatment blind Follow-up 5

Status of treatment blind
Beschrijving

Status of treatment blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Beschrijving

If yes, complete the Adverse Event form and/or Investigational Product form as appropriate. Time blind broken is optional.

Datatype

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0087111
Date blind broken
Beschrijving

Date blind broken

Datatype

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Time blind broken
Beschrijving

Optional

Datatype

time

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0040223
Reason blind broken
Beschrijving

Reason blind broken

Datatype

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Reason blind broken other, specify:
Beschrijving

Reason blind broken other

Datatype

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C1521902

Similar models

Status of treatment blind Follow-up 5

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Status of treatment blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Item
Was the treatment blind broken during the study?
integer
C3897431 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Code List
Was the treatment blind broken during the study?
CL Item
No (1)
CL Item
Yes, complete the following: (2)
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time blind broken
Item
Time blind broken
time
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify: (2)
Reason blind broken other
Item
Reason blind broken other, specify:
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])

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