ID
40944
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
Mots-clés
Versions (2)
- 21/04/2020 21/04/2020 -
- 07/06/2020 07/06/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
7 juin 2020
DOI
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Licence
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
Description
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
Description
concomitant medications
Type de données
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
Description
non-serious adverse events
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0681850
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008972
Description
serious adverse events
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0681850
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008972
Description
abnormal ECG measurements
Type de données
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
Description
repeat haematology, clinical chemistry or urinalysis samples
Type de données
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
Description
repeat ECGs
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0205341
Description
repeat vital signs
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Description
PK: pharmacokinetic
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0031327
- UMLS CUI [1,3]
- C0205341
Description
PD: Pharmacodynamic
Type de données
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])