ID
41055
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 (3)
- 2020-04-25 2020-04-25 -
- 2020-06-07 2020-06-07 -
- 2020-06-17 2020-06-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
17 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 Imaging - Repeating Form, Liver Event 7-RF-DF
- StudyEvent: ODM
Beskrivning
What method was used for this imaging test?
Alias
- UMLS CUI-1
- C1275506
Beskrivning
method used for imaging test
Datatyp
text
Alias
- UMLS CUI [1]
- C1275506
Beskrivning
other method used for imaging test
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1275506
- UMLS CUI [1,2]
- C3845569
Beskrivning
Are images technically adequate?
Alias
- UMLS CUI-1
- C0806487
- UMLS CUI-2
- C0205410
Beskrivning
Indicate the liver size
Alias
- UMLS CUI-1
- C0426688
Beskrivning
Indicate the liver texture
Alias
- UMLS CUI-1
- C0679033
- UMLS CUI-2
- C0023884
Beskrivning
Grade the diffuse and/or geographic fatty infiltrate of the liver
Alias
- UMLS CUI-1
- C0015695
- UMLS CUI-2
- C0205219
- UMLS CUI-3
- C1517526
- UMLS CUI-4
- C0332448
Beskrivning
diffuse and/or geographic fatty infiltrate of the liver
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [1,3]
- C1517526
- UMLS CUI [1,4]
- C0332448
- UMLS CUI [1,5]
- C0205430
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C0205219
- UMLS CUI [2,3]
- C0332448
- UMLS CUI [3,1]
- C0015695
- UMLS CUI [3,2]
- C1517526
- UMLS CUI [3,3]
- C0332448
Beskrivning
other grade of diffuse and/or geographic fatty infiltrate of the liver
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [1,3]
- C1517526
- UMLS CUI [1,4]
- C0205430
- UMLS CUI [1,5]
- C3845569
- UMLS CUI [1,6]
- C0332448
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C0205219
- UMLS CUI [2,3]
- C3845569
- UMLS CUI [2,4]
- C0332448
- UMLS CUI [3,1]
- C0015695
- UMLS CUI [3,2]
- C1517526
- UMLS CUI [3,3]
- C3845569
- UMLS CUI [3,4]
- C0332448
Beskrivning
Ascites present
Alias
- UMLS CUI-1
- C0003962
Beskrivning
Are Focal Hepatic Lesions characterisable?
Alias
- UMLS CUI-1
- C0577053
- UMLS CUI-2
- C0205234
- UMLS CUI-3
- C1880022
Beskrivning
Focal Hepatic Lesions characterisable
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C1880022
Beskrivning
Solid Focal Hepatic Lesions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205208
Beskrivning
Cystic Focal Hepatic Lesions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205207
Beskrivning
Hemangioma Focal Hepatic Lesions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0018916
Beskrivning
Focal Nodular Hyperplasia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0020510
Beskrivning
Other Focal Hepatic Lesions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Beskrivning
Other Focal Hepatic Lesions specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C3845569
Beskrivning
Gallstones or gallbladder lesions?
Alias
- UMLS CUI-1
- C3842395
Beskrivning
Gallstones or gallbladder lesions
Datatyp
text
Alias
- UMLS CUI [1]
- C3842395
Beskrivning
Gallstones
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0008350
Beskrivning
Gallbladder polyps
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262493
Beskrivning
Sludge
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0860209
Beskrivning
Gallbladder wall thickening/oedema
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0744257
- UMLS CUI [2,1]
- C0734014
- UMLS CUI [2,2]
- C0013604
Beskrivning
Gallbladder wall gas
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0734014
- UMLS CUI [1,2]
- C0333139
Beskrivning
Cholecystitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0008325
Beskrivning
Gallbladder wall calcification
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0734014
- UMLS CUI [1,2]
- C1533591
Beskrivning
Gallbladder mass
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3874422
Beskrivning
Other gallbladder lesions
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0156213
Beskrivning
Other gallbladder lesions specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0156213
- UMLS CUI [1,2]
- C2348235
Beskrivning
Biliary ductal lesions?
Alias
- UMLS CUI-1
- C0005423
- UMLS CUI-2
- C0221198
Beskrivning
Biliary ductal lesions
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
Beskrivning
Intrahepatic ductal dilation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227481
Beskrivning
Intrahepatic ductal dilation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
Beskrivning
Extrahepatic ductal dilation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0206187
- UMLS CUI [1,2]
- C0012359
Beskrivning
Diffuse ductal dilation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0940779
Beskrivning
Acute Cholangitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0267917
Beskrivning
Primary sclerosing cholangitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0566602
Beskrivning
Choledocholithiasis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0701818
Beskrivning
Ductal filling defect other than gallstone
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1512083
- UMLS CUI [1,2]
- C0332555
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0242216
Beskrivning
Ductal wall thickening or oedema
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1180044
- UMLS CUI [1,2]
- C0205400
- UMLS CUI [2,1]
- C1180044
- UMLS CUI [2,2]
- C0013604
Beskrivning
Choledochal cyst
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0008340
Beskrivning
Ductal mass
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0577559
Beskrivning
Extrinsic mass compressing bile duct
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205101
- UMLS CUI [1,2]
- C0577559
- UMLS CUI [1,3]
- C0332260
- UMLS CUI [1,4]
- C0005400
Beskrivning
Other Biliary ductal lesions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0205394
Beskrivning
Other Biliary ductal lesions specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C3845569
Beskrivning
Portal/Hepatic vein abnormalities?
Alias
- UMLS CUI-1
- C0032718
- UMLS CUI-2
- C0019155
- UMLS CUI-3
- C1704258
Beskrivning
Portal/Hepatic vein abnormalities?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0019155
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [3,1]
- C0032718
- UMLS CUI [3,2]
- C0019155
- UMLS CUI [3,3]
- C1704258
- UMLS CUI [3,4]
- C0205430
Beskrivning
Portal vein enlargement
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0700124
Beskrivning
Hepatic vein enlargement
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C0700124
Beskrivning
Nonocclusive portal vein thrombosis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333204
Beskrivning
Occlusive portal vein thrombosis - bland
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333203
- UMLS CUI [1,3]
- C1518371
Beskrivning
Hepatic vein thrombosis - bland
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C1518371
Beskrivning
Occlusive portal vein thrombosis - malignant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333203
- UMLS CUI [1,3]
- C0205282
Beskrivning
Hepatic vein thrombosis - malignant
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C0205282
Beskrivning
Involvement of the main portal vein
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1183135
- UMLS CUI [1,2]
- C1314939
Beskrivning
Involvement of the right portal vein
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0226730
- UMLS CUI [1,2]
- C1314939
Beskrivning
Involvement of the left portal vein
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0933785
- UMLS CUI [1,2]
- C1314939
Beskrivning
Budd-Chiari syndrome
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0856761
Beskrivning
Other Portal/Hepatic vein abnormalities
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2,1]
- C0019155
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [2,3]
- C0205394
- UMLS CUI [3,1]
- C0032718
- UMLS CUI [3,2]
- C0019155
- UMLS CUI [3,3]
- C1704258
- UMLS CUI [3,4]
- C0205430
- UMLS CUI [3,5]
- C0205394
Beskrivning
Other Portal/Hepatic vein abnormalities specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C3845569
- UMLS CUI [2,1]
- C0019155
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [2,3]
- C3845569
- UMLS CUI [3,1]
- C0032718
- UMLS CUI [3,2]
- C0019155
- UMLS CUI [3,3]
- C1704258
- UMLS CUI [3,4]
- C0205430
- UMLS CUI [3,5]
- C3845569
Similar models
Liver Imaging - Repeating Form, Liver Event 7-RF-DF
- StudyEvent: ODM
C0011008 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0860888 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C3845569 (UMLS CUI [1,2])
C0205410 (UMLS CUI-2)
C0205410 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C3845569 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
C0023890 (UMLS CUI-2)
(Comment:en)
C0023884 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0205219 (UMLS CUI-2)
C1517526 (UMLS CUI-3)
C0332448 (UMLS CUI-4)
C0205219 (UMLS CUI [1,2])
C1517526 (UMLS CUI [1,3])
C0332448 (UMLS CUI [1,4])
C0205430 (UMLS CUI [1,5])
C0015695 (UMLS CUI [2,1])
C0205219 (UMLS CUI [2,2])
C0332448 (UMLS CUI [2,3])
C0015695 (UMLS CUI [3,1])
C1517526 (UMLS CUI [3,2])
C0332448 (UMLS CUI [3,3])
C0205219 (UMLS CUI [1,2])
C1517526 (UMLS CUI [1,3])
C0205430 (UMLS CUI [1,4])
C3845569 (UMLS CUI [1,5])
C0332448 (UMLS CUI [1,6])
C0015695 (UMLS CUI [2,1])
C0205219 (UMLS CUI [2,2])
C3845569 (UMLS CUI [2,3])
C0332448 (UMLS CUI [2,4])
C0015695 (UMLS CUI [3,1])
C1517526 (UMLS CUI [3,2])
C3845569 (UMLS CUI [3,3])
C0332448 (UMLS CUI [3,4])
C3845569 (UMLS CUI [1,2])
C0205234 (UMLS CUI-2)
C1880022 (UMLS CUI-3)
C0205234 (UMLS CUI [1,2])
C1880022 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0205208 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0205207 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0018916 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0020510 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0734014 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])
C0333139 (UMLS CUI [1,2])
C1533591 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0221198 (UMLS CUI-2)
C0221198 (UMLS CUI [1,2])
C0012359 (UMLS CUI [1,2])
C0227481 (UMLS CUI [1,3])
C0012359 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C0012359 (UMLS CUI [1,2])
C0332555 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0242216 (UMLS CUI [1,4])
C0205400 (UMLS CUI [1,2])
C1180044 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])
C0577559 (UMLS CUI [1,2])
C0577559 (UMLS CUI [1,2])
C0332260 (UMLS CUI [1,3])
C0005400 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0019155 (UMLS CUI-2)
C1704258 (UMLS CUI-3)
C1704258 (UMLS CUI [1,2])
C0019155 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0032718 (UMLS CUI [3,1])
C0019155 (UMLS CUI [3,2])
C1704258 (UMLS CUI [3,3])
C0205430 (UMLS CUI [3,4])
C0700124 (UMLS CUI [1,2])
C0700124 (UMLS CUI [1,2])
C0333204 (UMLS CUI [1,2])
C0333203 (UMLS CUI [1,2])
C1518371 (UMLS CUI [1,3])
C1518371 (UMLS CUI [1,2])
C0333203 (UMLS CUI [1,2])
C0205282 (UMLS CUI [1,3])
C0205282 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0019155 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0032718 (UMLS CUI [3,1])
C0019155 (UMLS CUI [3,2])
C1704258 (UMLS CUI [3,3])
C0205430 (UMLS CUI [3,4])
C0205394 (UMLS CUI [3,5])
C1704258 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0019155 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C3845569 (UMLS CUI [2,3])
C0032718 (UMLS CUI [3,1])
C0019155 (UMLS CUI [3,2])
C1704258 (UMLS CUI [3,3])
C0205430 (UMLS CUI [3,4])
C3845569 (UMLS CUI [3,5])