ID
40944
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
Versies (2)
- 21-04-20 21-04-20 -
- 07-06-20 07-06-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
7 juni 2020
DOI
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Licentie
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
Beschrijving
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
Beschrijving
concomitant medications
Datatype
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
Beschrijving
non-serious adverse events
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0681850
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008972
Beschrijving
serious adverse events
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0681850
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008972
Beschrijving
abnormal ECG measurements
Datatype
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
Beschrijving
repeat haematology, clinical chemistry or urinalysis samples
Datatype
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
Beschrijving
repeat ECGs
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0205341
Beschrijving
repeat vital signs
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Beschrijving
PK: pharmacokinetic
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0031327
- UMLS CUI [1,3]
- C0205341
Beschrijving
PD: Pharmacodynamic
Datatype
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])