ID
40951
Beskrivning
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
Nyckelord
Versioner (2)
- 2020-04-24 2020-04-24 -
- 2020-06-07 2020-06-07 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
7 juni 2020
DOI
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Licens
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
Liver Events, Liver Event 2-DF
- StudyEvent: ODM
Beskrivning
Liver events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beskrivning
subject age
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205847
- UMLS CUI [2]
- C0596728
- UMLS CUI [3]
- C0178694
Beskrivning
If yes, ensure Pregnancy Notification Form has been completed.
Datatyp
text
Alias
- UMLS CUI [1]
- C0032961
Beskrivning
diagnostic imaging of liver or hepatobiliary system
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1711359
- UMLS CUI [1,2]
- C0011923
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0023884
Beskrivning
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1711359
- UMLS CUI [1,2]
- C0011923
- UMLS CUI [1,3]
- C1319347
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0023884
- UMLS CUI [2,3]
- C1319347
Beskrivning
If yes, complete Liver Biopsy form.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0193388
Beskrivning
If yes, record on the appropriate Concomitant Medication form.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C1360419
- UMLS CUI [2,1]
- C0681850
- UMLS CUI [2,2]
- C1524063
- UMLS CUI [2,3]
- C0936077
- UMLS CUI [3,1]
- C0681850
- UMLS CUI [3,2]
- C1524063
- UMLS CUI [3,3]
- C0242295
- UMLS CUI [4,1]
- C0681850
- UMLS CUI [4,2]
- C0281875
Beskrivning
dietary change
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C3671772
- UMLS CUI [2,1]
- C0681850
- UMLS CUI [2,2]
- C0015663
Similar models
Liver Events, Liver Event 2-DF
- StudyEvent: ODM
C1254595 (UMLS CUI-2)
C2746065 (UMLS CUI-3)
C0243161 (UMLS CUI-4)
C4688482 (UMLS CUI-5)
C2599718 (UMLS CUI-6)
C1550543 (UMLS CUI-7)
C0587081 (UMLS CUI [1,2])
C0023901 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0596728 (UMLS CUI [2])
C0178694 (UMLS CUI [3])
C0011923 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0011923 (UMLS CUI [1,2])
C1319347 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C1319347 (UMLS CUI [2,3])
C1524063 (UMLS CUI [1,2])
C1360419 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0936077 (UMLS CUI [2,3])
C0681850 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0242295 (UMLS CUI [3,3])
C0681850 (UMLS CUI [4,1])
C0281875 (UMLS CUI [4,2])
C3671772 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])