ID
40485
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 (3)
- 4/25/20 4/25/20 -
- 6/7/20 6/7/20 -
- 6/17/20 6/17/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 25, 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 Imaging Repeating Form
- StudyEvent: ODM
Description
What method was used for this imaging test?
Alias
- UMLS CUI-1
- C1275506
Description
method used for imaging test
Data type
text
Alias
- UMLS CUI [1]
- C1275506
Description
other method used for imaging test
Data type
text
Alias
- UMLS CUI [1,1]
- C1275506
- UMLS CUI [1,2]
- C3845569
Description
Are images technically adequate?
Alias
- UMLS CUI-1
- C0806487
- UMLS CUI-2
- C0205410
Description
Indicate the liver size
Alias
- UMLS CUI-1
- C0426688
Description
Indicate the liver texture
Alias
- UMLS CUI-1
- C0679033
- UMLS CUI-2
- C0023884
Description
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
Description
diffuse and/or geographic fatty infiltrate of the liver
Data type
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
Description
other grade of diffuse and/or geographic fatty infiltrate of the liver
Data type
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
Description
Ascites present
Alias
- UMLS CUI-1
- C0003962
- UMLS CUI-2
- C0150312
Description
Are Focal Hepatic Lesions characterisable?
Alias
- UMLS CUI-1
- C0577053
- UMLS CUI-2
- C0205234
- UMLS CUI-3
- C1880022
Description
Focal Hepatic Lesions characterisable
Data type
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C1880022
Description
Solid Focal Hepatic Lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205208
Description
Cystic Focal Hepatic Lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205207
Description
Hemangioma Focal Hepatic Lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0018916
Description
Focal Nodular Hyperplasia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0020510
Description
Other Focal Hepatic Lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Description
Other Focal Hepatic Lesions specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C3845569
Description
Gallstones or gallbladder lesions?
Description
Gallstones or gallbladder lesions
Data type
text
Alias
- UMLS CUI [1,1]
- C0008350
- UMLS CUI [1,2]
- C0577068
Description
Gallstones
Data type
boolean
Alias
- UMLS CUI [1]
- C0008350
Description
Gallbladder polyps
Data type
boolean
Alias
- UMLS CUI [1]
- C0262493
Description
Sludge
Data type
boolean
Alias
- UMLS CUI [1]
- C0860209
Description
Gallbladder wall thickening/oedema
Data type
boolean
Alias
- UMLS CUI [1]
- C0744257
Description
Gallbladder wall gas
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0734014
- UMLS CUI [1,2]
- C0333139
Description
Cholecystitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0008325
Description
Gallbladder wall calcification
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0734014
- UMLS CUI [1,2]
- C1533591
Description
Gallbladder mass
Data type
boolean
Alias
- UMLS CUI [1]
- C3874422
Description
Other gallbladder lesions
Data type
boolean
Alias
- UMLS CUI [1]
- C0156213
Description
Other gallbladder lesions specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0156213
- UMLS CUI [1,2]
- C2348235
Description
Biliary ductal lesions?
Alias
- UMLS CUI-1
- C0005423
- UMLS CUI-2
- C0221198
Description
Biliary ductal lesions
Data type
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
Description
Intrahepatic ductal dilation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227481
Description
Intrahepatic ductal dilation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
Description
Extrahepatic ductal dilation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0206187
- UMLS CUI [1,2]
- C0012359
Description
Diffuse ductal dilation
Data type
boolean
Alias
- UMLS CUI [1]
- C0940779
Description
Acute Cholangitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0267917
Description
Primary sclerosing cholangitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0566602
Description
Choledocholithiasis
Data type
boolean
Alias
- UMLS CUI [1]
- C0701818
Description
Ductal filling defect other than gallstone
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1512083
- UMLS CUI [1,2]
- C0332555
- UMLS CUI [1,3]
- C4723751
- UMLS CUI [1,4]
- C0008350
Description
Ductal wall thickening or oedema
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1180044
- UMLS CUI [1,2]
- C0205400
- UMLS CUI [2,1]
- C1180044
- UMLS CUI [2,2]
- C0013604
Description
Choledochal cyst
Data type
boolean
Alias
- UMLS CUI [1]
- C0008340
Description
Ductal mass
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0577559
- UMLS CUI [1,3]
- C0333170
Description
Extrinsic mass compressing bile duct
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0577559
- UMLS CUI [1,3]
- C0333171
Description
Other Biliary ductal lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0205394
Description
Other Biliary ductal lesions specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C3845569
Description
Portal/Hepatic vein abnormalities?
Alias
- UMLS CUI-1
- C0032718
- UMLS CUI-2
- C0019155
- UMLS CUI-3
- C1704258
Description
Portal/Hepatic vein abnormalities?
Data type
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
Description
Portal vein enlargement
Data type
boolean
Alias
- UMLS CUI [1]
- C3544228
Description
Hepatic vein enlargement
Data type
boolean
Alias
- UMLS CUI [1]
- C2609157
Description
Nonocclusive portal vein thrombosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333204
Description
Occlusive portal vein thrombosis - bland
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333203
- UMLS CUI [1,3]
- C1518371
Description
Hepatic vein thrombosis - bland
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C1518371
Description
Occlusive portal vein thrombosis - malignant
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333203
- UMLS CUI [1,3]
- C0205282
Description
Hepatic vein thrombosis - malignant
Data type
text
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C0205282
Description
Involvement of the main portal vein
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1183135
- UMLS CUI [1,2]
- C1314939
Description
Involvement of the right portal vein
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0226730
- UMLS CUI [1,2]
- C1314939
Description
Involvement of the left portal vein
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0933785
- UMLS CUI [1,2]
- C1314939
Description
Budd-Chiari syndrome
Data type
boolean
Alias
- UMLS CUI [1]
- C0856761
Description
Other Portal/Hepatic vein abnormalities
Data type
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
Description
Other Portal/Hepatic vein abnormalities specification
Data type
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
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C0205219 (UMLS CUI [1,2])
C1517526 (UMLS CUI [1,3])
C0205430 (UMLS CUI [1,4])
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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])
C0150312 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
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])
C0577068 (UMLS CUI [1,2])
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])
C4723751 (UMLS CUI [1,3])
C0008350 (UMLS CUI [1,4])
C0205400 (UMLS CUI [1,2])
C1180044 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])
C0577559 (UMLS CUI [1,2])
C0333170 (UMLS CUI [1,3])
C0577559 (UMLS CUI [1,2])
C0333171 (UMLS CUI [1,3])
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])
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])