ID

30854

Beskrivning

This ODM file contains Collection Information on Pharmacodynamics and Pharmacokinetics. To be filled at Sessions 1 and 2 (Day 1, different timepoints). 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

  1. 2018-06-27 2018-06-27 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

27 juni 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

Pharmacodynamics and -kinetics (Sessions 1 and 2)

Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Type
Beskrivning

Form needs to be filled out on each attended visit mentioned below.

Datatyp

text

Alias
UMLS CUI [1]
C0545082
Pharmacodynamics - Blood (Biomarker)
Beskrivning

Pharmacodynamics - Blood (Biomarker)

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0005516
UMLS CUI-3
C0005834
Planned Relative Time
Beskrivning

Time relative to dosing

Datatyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0851347
Date sample taken
Beskrivning

Date sample taken

Datatyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0851347
Actual Time sample taken
Beskrivning

Time sample taken

Datatyp

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0851347
Sample Number
Beskrivning

Sample Number

Datatyp

text

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C0851347
Pharmacokinetics - Blood
Beskrivning

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005834
Planned relative Time and Sample Number
Beskrivning

Time relative to dosing Session 1: Sample Numbers with 1 in front (Unscheduled with 1 last) Session 2: Sample Numbers with 2 in front (unscheduled with 2 last)

Datatyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0031328
Date sample Taken
Beskrivning

Date sample Taken

Datatyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0201734
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0201734
Was sample missed or lost?
Beskrivning

(Originally: If sample is missed or lost, write "NA" in the Date Sample Taken column. )

Datatyp

boolean

Alias
UMLS CUI [1]
C3845781
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C1705492

Similar models

Pharmacodynamics and -kinetics (Sessions 1 and 2)

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Code List
Subject Identifier
Item
Visit Type
text
C0545082 (UMLS CUI [1])
Code List
Visit Type
CL Item
Session 1 (Session 1)
CL Item
Session 2 (Session 2)
Item Group
Pharmacodynamics - Blood (Biomarker)
C0851347 (UMLS CUI-1)
C0005516 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0851347 (UMLS CUI [1,3])
Code List
Planned Relative Time
CL Item
Pre-dose (Pre-dose)
CL Item
2 hrs (2 hrs)
CL Item
48 hrs (48 hrs)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0851347 (UMLS CUI [1,2])
Time sample taken
Item
Actual Time sample taken
text
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0851347 (UMLS CUI [1,3])
Sample Number
Item
Sample Number
text
C1299222 (UMLS CUI [1,1])
C0851347 (UMLS CUI [1,2])
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Item
Planned relative Time and Sample Number
text
C0439564 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
Code List
Planned relative Time and Sample Number
CL Item
Pre-dose (101)
CL Item
0.5 hrs (102)
CL Item
1 hrs (103)
CL Item
1.5 hrs (104)
CL Item
3 hrs (pre-scan) (105)
CL Item
4 hrs (post-scan) (106)
CL Item
5 hrs (107)
CL Item
6 hrs (108)
CL Item
12 hrs (109)
CL Item
24 hrs (110)
CL Item
48 hrs (111)
CL Item
72 hrs (112)
CL Item
Unscheduled (901)
CL Item
Pre-dose (201)
CL Item
0.5 hrs (202)
CL Item
1 hrs (203)
CL Item
1.5 hrs (204)
CL Item
3 hrs (pre-scan) (205)
CL Item
4 hrs (post-scan) (206)
CL Item
5 hrs (207)
CL Item
6 hrs (208)
CL Item
12 hrs (209)
CL Item
24 hrs (210)
CL Item
48 hrs (211)
CL Item
72 hrs (212)
CL Item
Unscheduled (902)
Date sample Taken
Item
Date sample Taken
date
C1302413 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,3])
Sample missed or lost
Item
Was sample missed or lost?
boolean
C3845781 (UMLS CUI [1])
C0005834 (UMLS CUI [2,1])
C1705492 (UMLS CUI [2,2])

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