ID
40951
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
Keywords
Versions (2)
- 4/24/20 4/24/20 -
- 6/7/20 6/7/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
June 7, 2020
DOI
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License
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
Description
Liver events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Description
subject age
Data type
boolean
Alias
- UMLS CUI [1]
- C0205847
- UMLS CUI [2]
- C0596728
- UMLS CUI [3]
- C0178694
Description
If yes, ensure Pregnancy Notification Form has been completed.
Data type
text
Alias
- UMLS CUI [1]
- C0032961
Description
diagnostic imaging of liver or hepatobiliary system
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1711359
- UMLS CUI [1,2]
- C0011923
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0023884
Description
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Data type
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
Description
If yes, complete Liver Biopsy form.
Data type
boolean
Alias
- UMLS CUI [1]
- C0193388
Description
If yes, record on the appropriate Concomitant Medication form.
Data type
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
Description
dietary change
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C3671772
- UMLS CUI [2,1]
- C0681850
- UMLS CUI [2,2]
- C0015663
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Liver Events, Liver Event 2-DF
- StudyEvent: ODM
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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])