ID
30312
Description
Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Liver Event - Liver Biopsy
Link
https://clinicaltrials.gov/ct2/show/NCT01036061
Keywords
Versions (2)
- 5/16/18 5/16/18 -
- 5/28/18 5/28/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 28, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061
Liver Biopsy
- StudyEvent: ODM
Description
Liver Architecture
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0935919
- UMLS CUI-3
- C0193388
Description
Liver Architecture
Data type
integer
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
Description
Liver Architecture
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
- UMLS CUI [1,3]
- C0205161
Description
Liver Architecture
Data type
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
Description
Bridging fibrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0016059
Description
Diffuse fibrosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0016059
- UMLS CUI [1,2]
- C0205219
Description
Nodular regenerative hyperplasia
Data type
boolean
Alias
- UMLS CUI [1]
- C0020510
Description
Congenital hepatic fibrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0009714
Description
Cirrhosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0023890
Description
Centrilobular congestion
Data type
boolean
Description
Endophlebitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0014234
Description
Veno-occlusive disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0948441
Description
Canalicular cholestasis
Data type
boolean
Alias
- UMLS CUI [1]
- C0008370
Description
Apoptosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0162638
Description
Focal hepatocellular necrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C1855038
Description
lnterface hepatitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0019158
Description
lschaemic necrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0027540
Description
Centrolobular (Zone 3) necrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0027540
Description
Focal coagulative necrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C1522058
Description
Centrolobular (Zone 3) coagulative necrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C1522058
Description
Bridging hepatocellular necrosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1855038
- UMLS CUI [1,2]
- C0333511
Description
Massive or panlobular hepatocellular necrosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1855038
- UMLS CUI [1,2]
- C0442131
Description
Dysplasia liver
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0334044
- UMLS CUI [1,2]
- C0023884
Description
Neoplasia liver
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1882062
- UMLS CUI [1,2]
- C0023884
Description
Description of Liver Cells or Hepatocytes
Alias
- UMLS CUI-1
- C0227525
- UMLS CUI-2
- C0678257
- UMLS CUI-3
- C0193388
Description
Description of Liver Cells or Hepatocytes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0678257
Description
Description of Liver Cells or Hepatocytes
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0678257
Description
Description of Liver Cells or Hepatocytes
Data type
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0678257
Description
Ballooning
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0333445
- UMLS CUI [1,2]
- C0227525
Description
Acidophilic
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0333931
- UMLS CUI [1,2]
- C0227525
Description
Pseudoxanthomatous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C3277905
Description
Multinucleated giant hepatocytes
Data type
boolean
Alias
- UMLS CUI [1]
- C4054455
Description
Liver Cell or Hepatocyte Inclusions or Vacuoles
Alias
- UMLS CUI-1
- C0227525
- UMLS CUI-2
- C0042219
- UMLS CUI-3
- C1512693
- UMLS CUI-4
- C0193388
Description
Liver Cell or Hepatocyte Inclusions or Vacuoles
Data type
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [2]
- C1512693
Description
Liver Cell or Hepatocyte Inclusions or Vacuoles
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [2]
- C1512693
Description
Liver Cell or Hepatocyte Inclusions or Vacuoles
Data type
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [2]
- C1512693
Description
Macrovesicular steatosis
Data type
boolean
Alias
- UMLS CUI [1]
- C1837256
Description
Microvesicular steatosis
Data type
boolean
Alias
- UMLS CUI [1]
- C1850415
Description
Bile accumulation
Data type
boolean
Alias
- UMLS CUI [1]
- C3686784
Description
Diastase-resistant, PAS-positive cytoplasmic inclusions
Data type
boolean
Alias
- UMLS CUI [1]
- C0205708
Description
Alpha-1-antitrypsin inclusions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002191
- UMLS CUI [1,2]
- C1512693
- UMLS CUI [1,3]
- C0227525
Description
Megamitochondria
Data type
boolean
Alias
- UMLS CUI [1]
- C0026237
Description
Mallory bodies
Data type
boolean
Alias
- UMLS CUI [1]
- C0333744
Description
Ground Glass inclusions
Data type
boolean
Alias
- UMLS CUI [1]
- C0598786
Description
Lipofuscin pigment
Data type
boolean
Alias
- UMLS CUI [1]
- C0023789
Description
Hemosiderin granules
Data type
boolean
Alias
- UMLS CUI [1]
- C0019113
Description
Orcein positive cytoplasmin granules
Data type
boolean
Alias
- UMLS CUI [1]
- C0069596
Description
Protoporphyrin crystals
Data type
boolean
Alias
- UMLS CUI [1]
- C0033733
Description
Uroporphyrin crystals
Data type
boolean
Alias
- UMLS CUI [1]
- C0042093
Description
Hepatocyte or Liver Cell Nuclear Abnormalities
Alias
- UMLS CUI-1
- C0227525
- UMLS CUI-2
- C1849376
- UMLS CUI-3
- C0193388
Description
Hepatocyte or Liver Cell Nuclear Abnormalities
Data type
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Description
Hepatocyte or Liver Cell Nuclear Abnormalities
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Description
Hepatocyte or Liver Cell Nuclear Abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Description
Hepatocellular mitosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0026255
- UMLS CUI [1,2]
- C2697585
Description
Binucleated or multinucleated hepatocytes
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0333909
- UMLS CUI [1,2]
- C4054455
Description
CMV inclusion bodies
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0010825
- UMLS CUI [1,2]
- C0227525
- UMLS CUI [1,3]
- C1512693
Description
HSV inclusions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0319232
- UMLS CUI [1,2]
- C0227525
- UMLS CUI [1,3]
- C1512693
Description
Varicella inclusions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0740380
- UMLS CUI [1,2]
- C0227525
- UMLS CUI [1,3]
- C1512693
Description
Liver or Lobular Infiltrates
Alias
- UMLS CUI-1
- C1400896
- UMLS CUI-2
- C0193388
Description
Liver or Lobular Infiltrates
Data type
boolean
Alias
- UMLS CUI [1]
- C1400896
Description
Liver or Lobular Infiltrates
Data type
boolean
Alias
- UMLS CUI [1]
- C1400896
Description
Liver or Lobular Infiltrates
Data type
text
Alias
- UMLS CUI [1]
- C1400896
Description
Eosinophils
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0014467
- UMLS CUI [1,2]
- C1400896
Description
Lymphocytes
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0024264
- UMLS CUI [1,2]
- C1400896
Description
Plasma cells
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032112
- UMLS CUI [1,2]
- C1400896
Description
Neutrophils
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027950
- UMLS CUI [1,2]
- C1400896
Description
Macrophages and proliferating Kupffer cells
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0022801
- UMLS CUI [1,2]
- C1400896
Description
Granulomas
Data type
boolean
Alias
- UMLS CUI [1]
- C0745754
Description
Portal Tract Inflammation
Alias
- UMLS CUI-1
- C3854488
- UMLS CUI-2
- C0193388
Description
Portal Tract Inflammation
Data type
boolean
Alias
- UMLS CUI [1]
- C3854488
Description
Portal Tract Inflammation
Data type
boolean
Alias
- UMLS CUI [1]
- C3854488
Description
Portal Tract Inflammation
Data type
text
Alias
- UMLS CUI [1]
- C3854488
Description
Eosinophils
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0014467
- UMLS CUI [1,2]
- C3854488
Description
Lymphoid aggregates and/or follicles
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0229653
- UMLS CUI [1,2]
- C3854488
Description
Plasma cells
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032112
- UMLS CUI [1,2]
- C3854488
Description
Neutrophils
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027950
- UMLS CUI [1,2]
- C3854488
Description
Histocytes and macrophages
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0024432
- UMLS CUI [1,2]
- C3854488
Description
Bile Ducts
Alias
- UMLS CUI-1
- C0005400
- UMLS CUI-2
- C0193388
Description
Bile Ducts
Data type
integer
Alias
- UMLS CUI [1]
- C0005400
Description
Bile Ducts
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0205161
Description
Bile Ducts
Data type
text
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0205161
Description
Proliferation of bile ducts
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0334094
Description
Dilation, degeneration or disruption of portal bile ducts
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0011164
Description
Paucity of bile ducts
Data type
boolean
Alias
- UMLS CUI [1]
- C4273160
Description
Periductal fibrosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0016059
- UMLS CUI [1,2]
- C0005400
Description
Portal veins
Alias
- UMLS CUI-1
- C0032718
- UMLS CUI-2
- C0193388
Description
Portal Veins
Data type
integer
Alias
- UMLS CUI [1]
- C0032718
Description
Portal Veins
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0205161
Description
Portal Veins
Data type
text
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0205161
Description
Pyelophlebitis
Data type
boolean
Alias
- UMLS CUI [1]
- C1405883
Description
Thrombosis, sclerosis or occlusion of portal vein
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0400960
Description
Neoplastic Invasion of portal vein
Data type
boolean
Alias
- UMLS CUI [1]
- C0585133
Description
Granulomatous compression of portal vein
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0439667
Description
Liver Infections
Alias
- UMLS CUI-1
- C1112211
- UMLS CUI-2
- C0193388
Description
Liver Infections
Data type
integer
Alias
- UMLS CUI [1]
- C1112211
Description
Liver Infections
Data type
boolean
Alias
- UMLS CUI [1]
- C1112211
Description
Liver Infections
Data type
text
Alias
- UMLS CUI [1]
- C1112211
Description
Leishmaniasis donovani
Data type
boolean
Alias
- UMLS CUI [1]
- C0023281
Description
Plasmodium falciparum
Data type
boolean
Alias
- UMLS CUI [1]
- C0032150
Description
Toxoplasmosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0040558
Description
Cryptococcus neoformans
Data type
boolean
Alias
- UMLS CUI [1]
- C0010416
Description
Histoplasma capsulatum
Data type
boolean
Alias
- UMLS CUI [1]
- C0319941
Description
Mycobacterium tuberculois
Data type
boolean
Alias
- UMLS CUI [1]
- C0026926
Description
Other mycobacterial species
Data type
boolean
Alias
- UMLS CUI [1]
- C0026912
Description
Parasites or Ova
Alias
- UMLS CUI-1
- C0030498
- UMLS CUI-2
- C0555117
- UMLS CUI-3
- C0023884
- UMLS CUI-4
- C0193388
Description
Parasites or ova
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2]
- C0555117
Description
Parasites or ova
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2]
- C0555117
Description
Parasites or ova
Data type
text
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2]
- C0555117
Description
Schistosome and/or ova
Data type
boolean
Alias
- UMLS CUI [1]
- C0036315
Description
Ascaris and/or ova
Data type
boolean
Alias
- UMLS CUI [1]
- C0003954
Description
Toxocara and/or ova
Data type
boolean
Alias
- UMLS CUI [1]
- C0040550
Description
Echinococcus cysts
Data type
boolean
Alias
- UMLS CUI [1]
- C0013502
Description
Hepatic capillariasis worms and/or ova
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0277202
- UMLS CUI [1,2]
- C0018889
Description
Histologic Staining or Additional Studies Obtained
Alias
- UMLS CUI-1
- C0487602
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0023884
- UMLS CUI-4
- C0193388
Description
Histologic Staining or Additional Studies Obtained
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0487602
- UMLS CUI [1,2]
- C0023884
Description
Histologic Staining or Additional Studies Obtained
Data type
text
Alias
- UMLS CUI [1,1]
- C0487602
- UMLS CUI [1,2]
- C0023884
Description
Haematoxylin and eosin
Data type
boolean
Alias
- UMLS CUI [1]
- C0523207
Description
Masson stain
Data type
boolean
Alias
- UMLS CUI [1]
- C3825641
Description
Toluidine blue or Giemsa
Data type
boolean
Alias
- UMLS CUI [1]
- C0523203
Description
Prussian blue
Data type
boolean
Alias
- UMLS CUI [1]
- C0060234
Description
Periodic Acidic Schiff (PAS)
Data type
boolean
Alias
- UMLS CUI [1]
- C0440048
Description
Oil red
Data type
boolean
Alias
- UMLS CUI [1]
- C1294000
Description
Congo red
Data type
boolean
Alias
- UMLS CUI [1]
- C0009742
Description
Hall's stain
Data type
boolean
Alias
- UMLS CUI [1]
- C1720394
Description
Gridley's stain
Data type
boolean
Alias
- UMLS CUI [1]
- C1293978
Description
Rhodanine (copper)
Data type
boolean
Alias
- UMLS CUI [1]
- C0035486
Description
Rubeanic acid (copper)
Data type
boolean
Alias
- UMLS CUI [1]
- C0073680
Description
Orce in, aldehyde fuchsin or Victoria blue
Data type
boolean
Alias
- UMLS CUI [1]
- C0491984
Description
Electronmicroscopy
Data type
boolean
Alias
- UMLS CUI [1]
- C0026019
Description
Hepatitls A lmmunostains positive
Data type
boolean
Alias
- UMLS CUI [1]
- C0560226
Description
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Data type
boolean
Alias
- UMLS CUI [1]
- C0149709
Description
Hepatitis D immunostains
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0850990
- UMLS CUI [1,2]
- C0021044
Description
Other immunostains
Data type
boolean
Alias
- UMLS CUI [1]
- C0021044
Similar models
Liver Biopsy
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C0935919 (UMLS CUI-2)
C0193388 (UMLS CUI-3)
C0935919 (UMLS CUI [1,2])
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C0935919 (UMLS CUI [1,2])
C0205219 (UMLS CUI [1,2])
C0333511 (UMLS CUI [1,2])
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C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C0678257 (UMLS CUI-2)
C0193388 (UMLS CUI-3)
C0678257 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,2])
C3277905 (UMLS CUI [1,2])
C0042219 (UMLS CUI-2)
C1512693 (UMLS CUI-3)
C0193388 (UMLS CUI-4)
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
C1512693 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,3])
C1849376 (UMLS CUI-2)
C0193388 (UMLS CUI-3)
C1849376 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,2])
C2697585 (UMLS CUI [1,2])
C4054455 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0193388 (UMLS CUI-2)
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
C0193388 (UMLS CUI-2)
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0334094 (UMLS CUI [1,2])
C0011164 (UMLS CUI [1,2])
C0005400 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0400960 (UMLS CUI [1,2])
C0439667 (UMLS CUI [1,2])
C0555117 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0193388 (UMLS CUI-4)
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
C0018889 (UMLS CUI [1,2])
C0430022 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0193388 (UMLS CUI-4)
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,2])