ID

40944

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. 4/21/20 4/21/20 -
  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

Logs and repeats Logs/Repeats 1

1 forms  
Date of visit/assessment
Description

Date of visit/assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Description

Date is the start of the study for this subject

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Adverse event/concomitant medication/repeat assessment check questions
Description

Adverse event/concomitant medication/repeat assessment check questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
UMLS CUI-3
C0205341
UMLS CUI-4
C0220825
Were any concomitant medications taken by the subject during the study?
Description

concomitant medications

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0681850
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C0008972
Did the subject experience any non-serious adverse events during the study?
Description

non-serious adverse events

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0008972
Did the subject experience any serious adverse events during the study?
Description

serious adverse events

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0008972
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Description

abnormal ECG measurements

Data type

integer

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008972
UMLS CUI [1,4]
C1832603
UMLS CUI [1,5]
C2985739
Were any repeat haematology, clinical chemistry or urinalysis samples taken?
Description

repeat haematology, clinical chemistry or urinalysis samples

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0205341
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0200345
UMLS CUI [2,3]
C0205341
UMLS CUI [3,1]
C0042014
UMLS CUI [3,2]
C0200345
UMLS CUI [3,3]
C0205341
Were any repeat ECGs performed?
Description

repeat ECGs

Data type

integer

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205341
Were any repeat vital signs recorded?
Description

repeat vital signs

Data type

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat PK blood samples taken?
Description

PK: pharmacokinetic

Data type

integer

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
UMLS CUI [1,3]
C0205341
Were any repeat PD samples taken?
Description

PD: Pharmacodynamic

Data type

integer

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0851347
UMLS CUI [1,3]
C0200345
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Similar models

Logs and repeats Logs/Repeats 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Adverse event/concomitant medication/repeat assessment check questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
Item
Were any concomitant medications taken by the subject during the study?
integer
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008972 (UMLS CUI [1,5])
concomitant medications
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
Yes (1)
CL Item
No (2)
Item
Did the subject experience any non-serious adverse events during the study?
integer
C1518404 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,4])
non-serious adverse events
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (1)
CL Item
No (2)
Item
Did the subject experience any serious adverse events during the study?
integer
C1519255 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,4])
serious adverse events
Code List
Did the subject experience any serious adverse events during the study?
CL Item
Yes (1)
CL Item
No (2)
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
integer
C0681850 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C1832603 (UMLS CUI [1,4])
C2985739 (UMLS CUI [1,5])
abnormal ECG measurements
Code List
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
CL Item
Yes (1)
CL Item
No (2)
Item
Were any repeat haematology, clinical chemistry or urinalysis samples taken?
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0042014 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
C0205341 (UMLS CUI [3,3])
repeat haematology, clinical chemistry or urinalysis samples
Code List
Were any repeat haematology, clinical chemistry or urinalysis samples taken?
CL Item
Yes (1)
CL Item
No (2)
Item
Were any repeat ECGs performed?
integer
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
repeat ECGs
Code List
Were any repeat ECGs performed?
CL Item
Yes (1)
CL Item
No (2)
Item
Were any repeat vital signs recorded?
integer
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
concomitant medications
Code List
Were any repeat vital signs recorded?
CL Item
Yes (1)
CL Item
No (2)
Item
Were any repeat PK blood samples taken?
integer
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
concomitant medications
Code List
Were any repeat PK blood samples taken?
CL Item
Yes (1)
CL Item
No (2)
Item
Were any repeat PD samples taken?
integer
C0205341 (UMLS CUI [1,1])
C0851347 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
concomitant medications
Code List
Were any repeat PD samples taken?
CL Item
Yes (1)
CL Item
No (2)
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