ID

40890

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. 5/31/20 5/31/20 -
  2. 6/7/20 6/7/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 31, 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

Acetaminophen (Dose)

1 forms  
  1. StudyEvent: ODM
    1. Acetaminophen (Dose)
Investigational Product
Description

Investigational Product

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

Date/time of dose

Data type

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
Description

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?
Description

Treatment confirmation

Data type

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:
Description

Treatment Confirmation No

Data type

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 forms
  1. StudyEvent: ODM
    1. Acetaminophen (Dose)
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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