ID

40982

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 (1)
  1. 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 V10 8-DF

1 forms  
  1. StudyEvent: ODM
    1. 12-lead ECG V10 8-DF
Dosing Date and Time
Description

Dosing Date and Time

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0013227
UMLS CUI-3
C0178602
UMLS CUI-4
C0011008
UMLS CUI-5
C0040223
Dosing date/time
Description

Item is not required

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Predose 1
Description

Predose 1

Alias
UMLS CUI-1
C0439565
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
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

Optional Item

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489636
msec
QRS Axis
Description

Optional Item

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
QTcB Interval
Description

QTcB Interval

Data type

float

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

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
Predose 2
Description

Predose 2

Alias
UMLS CUI-1
C0439565
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
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

Optional Item

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489636
msec
QRS Axis
Description

Optional Item

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
QTcB Interval
Description

QTcB Interval

Data type

float

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

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
Predose 3
Description

Predose 3

Alias
UMLS CUI-1
C0439565
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
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

Optional Item

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489636
msec
QRS Axis
Description

Optional Item

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
QTcB Interval
Description

QTcB Interval

Data type

float

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

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
2 Hours
Description

2 Hours

Alias
UMLS CUI-1
C0439568
UMLS CUI-2
C0040223
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
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

Optional Item

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489636
msec
QRS Axis
Description

Optional Item

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
QTcB Interval
Description

QTcB Interval

Data type

float

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

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
6 Hours
Description

6 Hours

Alias
UMLS CUI-1
C0439568
UMLS CUI-2
C0040223
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
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

Optional Item

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489636
msec
QRS Axis
Description

Optional Item

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
QTcB Interval
Description

QTcB Interval

Data type

float

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

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
24 Hours
Description

24 Hours

Alias
UMLS CUI-1
C0439568
UMLS CUI-2
C0040223
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
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

Optional Item

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489636
msec
QRS Axis
Description

Optional Item

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
QTcB Interval
Description

QTcB Interval

Data type

float

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

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

12-lead ECG V10 8-DF

1 forms
  1. StudyEvent: ODM
    1. 12-lead ECG V10 8-DF
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Dosing Date and Time
C0430456 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
C0040223 (UMLS CUI-5)
Dosing date/time
Item
Dosing date/time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Predose 1
C0439565 (UMLS CUI-1)
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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
C0489636 (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])
QTcB Interval
Item
QTcB Interval
float
C0855331 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal- clinically significant (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) (3)
CL Item
No result (not available) (4)
Item Group
Predose 2
C0439565 (UMLS CUI-1)
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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
C0489636 (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])
QTcB Interval
Item
QTcB Interval
float
C0855331 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal- clinically significant (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) (3)
CL Item
No result (not available) (4)
Item Group
Predose 3
C0439565 (UMLS CUI-1)
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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
C0489636 (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])
QTcB Interval
Item
QTcB Interval
float
C0855331 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal- clinically significant (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) (3)
CL Item
No result (not available) (4)
Item Group
2 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-2)
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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
C0489636 (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])
QTcB Interval
Item
QTcB Interval
float
C0855331 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal- clinically significant (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) (3)
CL Item
No result (not available) (4)
Item Group
6 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-2)
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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
C0489636 (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])
QTcB Interval
Item
QTcB Interval
float
C0855331 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal- clinically significant (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) (3)
CL Item
No result (not available) (4)
Item Group
24 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-2)
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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
C0489636 (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])
QTcB Interval
Item
QTcB Interval
float
C0855331 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal- clinically significant (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) (3)
CL Item
No result (not available) (4)
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