ID
30926
Beskrivning
This ODM file contains Information about Liver Events. Use separate forms for each liver event. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.
Länk
https://clinicaltrials.gov/ct2/show/NCT01039454
Nyckelord
Versioner (1)
- 2018-07-03 2018-07-03 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
3 juli 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454
Liver Events
- StudyEvent: ODM
Beskrivning
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C0587081
- UMLS CUI-4
- C0304229
- UMLS CUI-5
- C2746065
Beskrivning
alanine aminotransferase increased
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0151905
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
Beskrivning
aspartate aminotransferase increased
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0151904
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
Beskrivning
Total bilirubin increased
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0741494
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
Beskrivning
Alkaline phosphatase increased
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0151849
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
Beskrivning
5’ nucleotidase increased
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0740292
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
Beskrivning
Gammaglutamyltranspeptidase increased
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0541979
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
Beskrivning
other laboratory finding increased
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C2746065
Beskrivning
Start and End Date of Investigational Product
Alias
- UMLS CUI-1
- C0808070
- UMLS CUI-2
- C0806020
- UMLS CUI-3
- C0304229
- UMLS CUI-4
- C1556667
Beskrivning
Only complete dates for the treatment period where the liver event occurred. If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1556667
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C0304229
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beskrivning
Stop Date, liver event during treatment period
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Beskrivning
Subject Factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C1556667
Beskrivning
Age above 55y
Datatyp
text
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
If Yes, ensure Pregnancy Notification Form has been completed.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1556667
Beskrivning
If Yes, record on the appropriate Concomitant Medication form.
Datatyp
text
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0281875
Beskrivning
Fasting, significant dietary change
Datatyp
text
Alias
- UMLS CUI [1]
- C3671772
- UMLS CUI [2]
- C0015663
Beskrivning
If the subject does not drink enter '0'. ALCOHOL CONVERTER 1 unit of alcohol in UK = 1 measure of spirits, 1/2 pint beer, 1 small glass of wine (125ml)
Datatyp
integer
Måttenheter
- units / week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C1556667
Beskrivning
Diagnostics
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C1556667
Beskrivning
liver or hepatobiliary system diagnostic imaging
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [1,3]
- C1556667
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0023884
- UMLS CUI [2,3]
- C1556667
Beskrivning
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C1556667
Beskrivning
If Yes, complete Liver Biopsy form.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1556667
Beskrivning
Unscheduled PK blood sample
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0201734
- UMLS CUI-3
- C1556667
Beskrivning
An unscheduled PK blood sample must be obtained within 24 hours of last dose.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1556667
Beskrivning
date and time sample taken
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0201734
- UMLS CUI [1,3]
- C1556667
- UMLS CUI [1,4]
- C1264639
Beskrivning
Date and time of last dose of experimental drug
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C1556667
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C1762893
- UMLS CUI [3,1]
- C0304229
- UMLS CUI [3,2]
- C0946444
Beskrivning
last dose prior to PK sample 1
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C1556667
- UMLS CUI [2]
- C1762893
- UMLS CUI [3]
- C0946444
Beskrivning
last dose prior to PK sample 2
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C1556667
- UMLS CUI [2]
- C1762893
- UMLS CUI [3]
- C0946444
Beskrivning
Sample Identifier Label
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [1,3]
- C0201734
- UMLS CUI [1,4]
- C1556667
Beskrivning
Sample Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0201734
- UMLS CUI [1,3]
- C1556667
Beskrivning
Specific Medical Conditions at onset of liver event
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C1556667
Beskrivning
DRUG RELATED LIVER DISEASE CONDITIONS: All drugs including Investigational Product
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1556667
Beskrivning
Option 5 not for Option 15 or 16 of "Specific condition" item
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3176928
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C1556667
Beskrivning
Specify Condition, if chosen 15 or 16 in "Specific Condition" item.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3843040
- UMLS CUI [1,2]
- C0023895
- UMLS CUI [1,3]
- C0262926
- UMLS CUI [1,4]
- C1556667
Similar models
Liver Events
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0008000 (UMLS CUI-2)
C0587081 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
C2746065 (UMLS CUI-5)
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
C0806020 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C1556667 (UMLS CUI-4)
C0439564 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1556667 (UMLS CUI [1,2])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0281875 (UMLS CUI [5])
C0015663 (UMLS CUI [2])
C1556667 (UMLS CUI [1,2])
C1711359 (UMLS CUI [1,2])
C1556667 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C1556667 (UMLS CUI [2,3])
C1274040 (UMLS CUI [1,2])
C1556667 (UMLS CUI [1,3])
C1556667 (UMLS CUI [1,2])
C0201734 (UMLS CUI-2)
C1556667 (UMLS CUI-3)
C0031328 (UMLS CUI [1,2])
C1556667 (UMLS CUI [1,3])
C0201734 (UMLS CUI [1,2])
C1556667 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,4])
C1556667 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1762893 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0946444 (UMLS CUI [3,2])
C1556667 (UMLS CUI [1,2])
C1762893 (UMLS CUI [2])
C0946444 (UMLS CUI [3])
C1556667 (UMLS CUI [1,2])
C1762893 (UMLS CUI [2])
C0946444 (UMLS CUI [3])
C0600091 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,3])
C1556667 (UMLS CUI [1,4])
C0201734 (UMLS CUI [1,2])
C1556667 (UMLS CUI [1,3])
C0262926 (UMLS CUI-2)
C1556667 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
C1556667 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C1556667 (UMLS CUI [1,3])
C0023895 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C1556667 (UMLS CUI [1,4])
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