ID

40936

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

  1. 4/18/20 4/18/20 -
  2. 4/18/20 4/18/20 -
  3. 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

Vital Signs Screen 3

  1. StudyEvent: ODM
    1. Vital Signs Screen 3
Measurement 1 (of 1)
Description

Measurement 1 (of 1)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0242485
UMLS CUI-3
C0220908
Actual date/time
Description

Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Waist circumference
Description

Waist circumference

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0455829
cm
Blood pressure systolic
Description

Blood pressure systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Description

Blood pressure diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Heart rate
Description

Heart rate

Data type

integer

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

Similar models

Vital Signs Screen 3

  1. StudyEvent: ODM
    1. Vital Signs Screen 3
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Measurement 1 (of 1)
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
Actual date/time
Item
Actual date/time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Waist circumference
Item
Waist circumference
integer
C0455829 (UMLS CUI [1])
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0871470 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])

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