ID
40944
Descripción
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
Palabras clave
Versiones (2)
- 21/4/20 21/4/20 -
- 7/6/20 7/6/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
7 de junio de 2020
DOI
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Licencia
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
Logs and repeats Logs/Repeats 1
- StudyEvent: ODM
Descripción
Adverse event/concomitant medication/repeat assessment check questions
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0205341
- UMLS CUI-4
- C0220825
Descripción
concomitant medications
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0681850
- UMLS CUI [1,4]
- C0347984
- UMLS CUI [1,5]
- C0008972
Descripción
non-serious adverse events
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0681850
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008972
Descripción
serious adverse events
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0681850
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008972
Descripción
abnormal ECG measurements
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008972
- UMLS CUI [1,4]
- C1832603
- UMLS CUI [1,5]
- C2985739
Descripción
repeat haematology, clinical chemistry or urinalysis samples
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0205341
- UMLS CUI [2,1]
- C0018941
- UMLS CUI [2,2]
- C0200345
- UMLS CUI [2,3]
- C0205341
- UMLS CUI [3,1]
- C0042014
- UMLS CUI [3,2]
- C0200345
- UMLS CUI [3,3]
- C0205341
Descripción
repeat ECGs
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0205341
Descripción
repeat vital signs
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Descripción
PK: pharmacokinetic
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0031327
- UMLS CUI [1,3]
- C0205341
Descripción
PD: Pharmacodynamic
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0851347
- UMLS CUI [1,3]
- C0200345
Similar models
Logs and repeats Logs/Repeats 1
- StudyEvent: ODM
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0013227 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008972 (UMLS CUI [1,5])
C0681850 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,4])
C0681850 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C1832603 (UMLS CUI [1,4])
C2985739 (UMLS CUI [1,5])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0042014 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
C0205341 (UMLS CUI [3,3])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0851347 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])