ID

40983

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

  1. 6/7/20 6/7/20 -
  2. 6/7/20 6/7/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 7, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

12-lead ECG V2 9-DF

  1. StudyEvent: ODM
    1. 12-lead ECG V2 9-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]