ID

40940

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 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

Keywords

Versions (2)
  1. 4/18/20 4/18/20 -
  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

12-lead ECG Follow-up 3

1 forms  
Measurement 1 (of 1)
Description

Measurement 1 (of 1)

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0242485
UMLS CUI-3
C1522577
Date and time of ECG
Description

Date and time of ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Description

PR Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
RR Interval
Description

RR Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Axis
Description

QRS Axis

Data type

integer

Measurement units
  • degrees
Alias
UMLS CUI [1]
C0429012
degrees
QRS Duration
Description

QRS Duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc Interval
Description

QTc Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0855331
msec
Result of the ECG
Description

If answer is "abnormal": complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE

Data type

integer

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Similar models

12-lead ECG Follow-up 3

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Measurement 1 (of 1)
C0430456 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
Date and time of ECG
Item
Date and time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
RR Interval
Item
RR Interval
float
C0429087 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
float
C0855331 (UMLS CUI [1])
Item
Result of the ECG
integer
ECG results
Code List
Result of the ECG
CL Item
Normal (1)
C0522054 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal - not clinically significant (2)
C0522055 (UMLS CUI-1)
C2826632 (UMLS CUI-2)
(Comment:en)
CL Item
Abnormal - clinically significant (3)
C0522055 (UMLS CUI-1)
C2826632 (UMLS CUI-2)
(Comment:en)
CL Item
No result (not available) (4)
C1706613 (UMLS CUI-1)
(Comment:en)
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