ID

40411

Beschrijving

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

Trefwoorden

  1. 18-04-20 18-04-20 -
  2. 07-06-20 07-06-20 -
  3. 07-06-20 07-06-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

18 april 2020

DOI

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Licentie

Creative Commons BY-NC 4.0

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40409_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 Follow-up

  1. StudyEvent: ODM
    1. Vital Signs Follow-up
Measurement 1 (of 1)
Beschrijving

Measurement 1 (of 1)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0242485
UMLS CUI-3
C1522577
Actual date/time
Beschrijving

Actual date/time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure systolic
Beschrijving

Blood pressure systolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Beschrijving

Blood pressure diastolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min

Similar models

Vital Signs Follow-up

  1. StudyEvent: ODM
    1. Vital Signs Follow-up
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Measurement 1 (of 1)
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
Actual date/time
Item
Actual date/time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Weight
Item
Weight
float
C0005910 (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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