ID

40890

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2020-05-31 2020-05-31 -
  2. 2020-06-07 2020-06-07 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

31 maj 2020

DOI

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Licens

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

Engelsk

Acetaminophen (Dose)

1 Formulär  
  1. StudyEvent: ODM
    1. Acetaminophen (Dose)
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0000970
Date/time of dose
Beskrivning

Date/time of dose

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0000970
Treatment Confirmation
Beskrivning

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beskrivning

Treatment confirmation

Datatyp

integer

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C2349182
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C0347984
UMLS CUI [1,6]
C0178602
UMLS CUI [1,7]
C1272706
If no, record reasons:
Beskrivning

Treatment Confirmation No

Datatyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C0205160
UMLS CUI [1,4]
C0392360
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Similar models

Acetaminophen (Dose)

1 Formulär
  1. StudyEvent: ODM
    1. Acetaminophen (Dose)
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
C0000970 (UMLS CUI-2)
Date/time of dose
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0000970 (UMLS CUI [1,5])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
integer
C0681850 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,5])
C0178602 (UMLS CUI [1,6])
C1272706 (UMLS CUI [1,7])
Treatment confirmation
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
Yes (1)
CL Item
No (2)
Treatment Confirmation No
Item
If no, record reasons:
text
C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C0205160 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Tillbaka till toppen 

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