ID

37507

Beschreibung

Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Stichworte

Versionen (2)
  1. 24.07.19 24.07.19 -
  2. 04.08.19 04.08.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. August 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957

Englisch

Day -1 - PET; Functional MRI Scan

1 Formulare  
Date of Visit
Beschreibung

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
PET - Scan 2
Beschreibung

PET - Scan 2

Alias
UMLS CUI-1
C0032743
Date of PET Scan 2
Beschreibung

Date of PET Scan 2

Datentyp

date

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0011008
PET Scan2 - Examination Number
Beschreibung

PET Scan 2 - Examination Number

Datentyp

integer

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0582103
UMLS CUI [2,2]
C0237753
PET Scan 2 - Radiochemical purity at release
Beschreibung

PET Scan 2 - Radiochemical purity at release

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0599914
UMLS CUI [2,2]
C0678739
UMLS CUI [2,3]
C1963578
UMLS CUI [2,4]
C0032743
%
PET Scan 2 - Radiochemical purity time at release
Beschreibung

PET Scan 2 - Radiochemical purity time at release

Datentyp

time

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0599914
UMLS CUI [2,2]
C0678739
UMLS CUI [2,3]
C0040223
UMLS CUI [2,4]
C1963578
UMLS CUI [2,5]
C0032743
PET Scan 2 - Mass of tracer administered
Beschreibung

PET Scan 2 - Mass of tracer administered

Datentyp

float

Maßeinheiten
  • ug
Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C1522485
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0032743
ug
PET Scan 2 - Volume to be administered (inc diluent)
Beschreibung

PET Scan 2 - Volume to be administered (inc diluent)

Datentyp

float

Maßeinheiten
  • mL
Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0449468
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0032743
mL
PET Scan 2 - Bolus activity injected
Beschreibung

PET Scan 2 - Bolus activity injected

Datentyp

float

Maßeinheiten
  • MBq/mL
Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C2986768
UMLS CUI [2,2]
C0205177
UMLS CUI [2,3]
C0032743
MBq/mL
PET Scan 2 - Bolus injection Start time
Beschreibung

PET Scan 2 - Bolus injection Start time

Datentyp

time

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C1511237
UMLS CUI [2,2]
C1301880
UMLS CUI [2,3]
C0032743
PET Scan 2 - Duration of bolus injection
Beschreibung

PET Scan 2 - Duration of bolus injection

Datentyp

durationDatetime

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C1511237
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0032743
PET Scan 2 - Constant infusion activity concentration (at start of infusion)
Beschreibung

PET Scan 2 - Constant infusion activity concentration (at start of infusion)

Datentyp

float

Maßeinheiten
  • MBq/mL
Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C0205177
UMLS CUI [2,3]
C0032743
MBq/mL
PET Scan 2 - Constant infusion start time
Beschreibung

PET Scan 2 - Constant infusion start time

Datentyp

time

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C1301880
UMLS CUI [2,3]
C0032743
PET Scan 2 - Constant infusion stop time
Beschreibung

PET Scan 2 - Constant infusion stop time

Datentyp

time

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C1522314
UMLS CUI [2,3]
C0032743
PET Scan 2 - Volume of constant infusion administered
Beschreibung

PET Scan 2 - Volume of constant infusion administered

Datentyp

float

Maßeinheiten
  • mL
Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C0449468
UMLS CUI [2,3]
C0032743
mL
Functional MRI Scan
Beschreibung

Functional MRI Scan

Alias
UMLS CUI-1
C0376335
Has an fMRI scan been carried out?
Beschreibung

Has an fMRI scan been carried out?

Datentyp

boolean

Alias
UMLS CUI [1]
C0376335
If fMRI has been carried out, enter date of fMRI Scan
Beschreibung

If fMRI has been carried out, enter date of fMRI Scan

Datentyp

date

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C0011008
fMRI Examination Number
Beschreibung

fMRI Examination Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C0582103
UMLS CUI [1,3]
C0237753
fMRI Scan start time
Beschreibung

fMRI Scan start time

Datentyp

time

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C1301880
fMRI Scan end time
Beschreibung

fMRI Scan end time

Datentyp

time

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C1522314
Describe any abnormal situation which ocurred during the fMRI scan.
Beschreibung

Leave blank if scan was without incident (e.g., ‘subject moved’, subject was coughing‘)

Datentyp

text

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2745955
PET - Scan 3
Beschreibung

PET - Scan 3

Alias
UMLS CUI-1
C0032743
Date of PET Scan 3
Beschreibung

Date of PET Scan 3

Datentyp

date

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0011008
PET Scan 3 - Examination Number
Beschreibung

PET Scan 3 - Examination Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0582103
UMLS CUI [1,3]
C0237753
PET Scan 3 - Radiochemical purity at release
Beschreibung

PET Scan 3 - Radiochemical purity at release

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0599914
UMLS CUI [2,2]
C0678739
UMLS CUI [2,3]
C1963578
UMLS CUI [2,4]
C0032743
%
PET Scan 3 - Radiochemical purity time at release
Beschreibung

PET Scan 3 - Radiochemical purity time at release

Datentyp

time

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0599914
UMLS CUI [2,2]
C0678739
UMLS CUI [2,3]
C0040223
UMLS CUI [2,4]
C1963578
UMLS CUI [2,5]
C0032743
PET Scan 3 - Mass of tracer administered
Beschreibung

PET Scan 3 - Mass of tracer administered

Datentyp

float

Maßeinheiten
  • ug
Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C1522485
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0032743
ug
PET Scan 3 - Volume to be administered (inc diluent)
Beschreibung

PET Scan 3 - Volume to be administered (inc diluent)

Datentyp

float

Maßeinheiten
  • mL
Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0449468
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0032743
mL
PET Scan 3 - Bolus activity injected
Beschreibung

PET Scan 3 - Bolus activity injected

Datentyp

float

Maßeinheiten
  • MBq/mL
Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C2986768
UMLS CUI [2,2]
C0205177
UMLS CUI [2,3]
C0032743
MBq/mL
PET Scan 3 - Bolus injection Start time
Beschreibung

PET Scan 3 - Bolus injection Start time

Datentyp

time

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C1511237
UMLS CUI [2,2]
C1301880
UMLS CUI [2,3]
C0032743
PET Scan 3 - Duration of bolus injection
Beschreibung

PET Scan 3 - Duration of bolus injection

Datentyp

durationDatetime

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C1511237
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0032743
PET Scan 3 - Constant infusion activity concentration (at start of infusion)
Beschreibung

PET Scan 3 - Constant infusion activity concentration (at start of infusion)

Datentyp

float

Maßeinheiten
  • MBq/mL
Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C0205177
UMLS CUI [2,3]
C0032743
MBq/mL
PET Scan 3 - Constant infusion start time
Beschreibung

PET Scan 3 - Constant infusion start time

Datentyp

time

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C1301880
UMLS CUI [2,3]
C0032743
PET Scan 3 - Constant infusion stop time
Beschreibung

PET Scan 3 - Constant infusion stop time

Datentyp

time

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C1522314
UMLS CUI [2,3]
C0032743
PET Scan 3 - Volume of constant infusion administered
Beschreibung

PET Scan 3 - Volume of constant infusion administered

Datentyp

float

Maßeinheiten
  • mL
Alias
UMLS CUI [1]
C0032743
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C0449468
UMLS CUI [2,3]
C0032743
mL
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Ähnliche Modelle

Day -1 - PET; Functional MRI Scan

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
PET - Scan 2
C0032743 (UMLS CUI-1)
Date of PET Scan 2
Item
Date of PET Scan 2
date
C0032743 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
PET Scan 2 - Examination Number
Item
PET Scan2 - Examination Number
integer
C0032743 (UMLS CUI [1])
C0582103 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
PET Scan 2 - Radiochemical purity at release
Item
PET Scan 2 - Radiochemical purity at release
integer
C0032743 (UMLS CUI [1])
C0599914 (UMLS CUI [2,1])
C0678739 (UMLS CUI [2,2])
C1963578 (UMLS CUI [2,3])
C0032743 (UMLS CUI [2,4])
PET Scan 2 - Radiochemical purity time at release
Item
PET Scan 2 - Radiochemical purity time at release
time
C0032743 (UMLS CUI [1])
C0599914 (UMLS CUI [2,1])
C0678739 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C1963578 (UMLS CUI [2,4])
C0032743 (UMLS CUI [2,5])
PET Scan 2 - Mass of tracer administered
Item
PET Scan 2 - Mass of tracer administered
float
C0032743 (UMLS CUI [1])
C1522485 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 2 - Volume to be administered (inc diluent)
Item
PET Scan 2 - Volume to be administered (inc diluent)
float
C0032743 (UMLS CUI [1])
C0449468 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 2 - Bolus activity injected
Item
PET Scan 2 - Bolus activity injected
float
C0032743 (UMLS CUI [1])
C2986768 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 2 - Bolus injection Start time
Item
PET Scan 2 - Bolus injection Start time
time
C0032743 (UMLS CUI [1])
C1511237 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 2 - Duration of bolus injection
Item
PET Scan 2 - Duration of bolus injection
durationDatetime
C0032743 (UMLS CUI [1])
C1511237 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 2 - Constant infusion activity concentration (at start of infusion)
Item
PET Scan 2 - Constant infusion activity concentration (at start of infusion)
float
C0032743 (UMLS CUI [1])
C0574032 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 2 - Constant infusion start time
Item
PET Scan 2 - Constant infusion start time
time
C0032743 (UMLS CUI [1])
C0574032 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 2 - Constant infusion stop time
Item
PET Scan 2 - Constant infusion stop time
time
C0032743 (UMLS CUI [1])
C0574032 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 2 - Volume of constant infusion administered
Item
PET Scan 2 - Volume of constant infusion administered
float
C0032743 (UMLS CUI [1])
C0574032 (UMLS CUI [2,1])
C0449468 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
Item Group
Functional MRI Scan
C0376335 (UMLS CUI-1)
Has an fMRI scan been carried out?
Item
Has an fMRI scan been carried out?
boolean
C0376335 (UMLS CUI [1])
If fMRI has been carried out, enter date of fMRI Scan
Item
If fMRI has been carried out, enter date of fMRI Scan
date
C0376335 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
fMRI Examination Number
Item
fMRI Examination Number
integer
C0376335 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
fMRI Scan start time
Item
fMRI Scan start time
time
C0376335 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
fMRI Scan end time
Item
fMRI Scan end time
time
C0376335 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Describe any abnormal situation which ocurred during the fMRI scan.
Item
Describe any abnormal situation which ocurred during the fMRI scan.
text
C0376335 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
Item Group
PET - Scan 3
C0032743 (UMLS CUI-1)
Date of PET Scan 3
Item
Date of PET Scan 3
date
C0032743 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
PET Scan 3 - Examination Number
Item
PET Scan 3 - Examination Number
integer
C0032743 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
PET Scan 3 - Radiochemical purity at release
Item
PET Scan 3 - Radiochemical purity at release
integer
C0032743 (UMLS CUI [1])
C0599914 (UMLS CUI [2,1])
C0678739 (UMLS CUI [2,2])
C1963578 (UMLS CUI [2,3])
C0032743 (UMLS CUI [2,4])
PET Scan 3 - Radiochemical purity time at release
Item
PET Scan 3 - Radiochemical purity time at release
time
C0032743 (UMLS CUI [1])
C0599914 (UMLS CUI [2,1])
C0678739 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C1963578 (UMLS CUI [2,4])
C0032743 (UMLS CUI [2,5])
PET Scan 3 - Mass of tracer administered
Item
PET Scan 3 - Mass of tracer administered
float
C0032743 (UMLS CUI [1])
C1522485 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 3 - Volume to be administered (inc diluent)
Item
PET Scan 3 - Volume to be administered (inc diluent)
float
C0032743 (UMLS CUI [1])
C0449468 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 3 - Bolus activity injected
Item
PET Scan 3 - Bolus activity injected
float
C0032743 (UMLS CUI [1])
C2986768 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 3 - Bolus injection Start time
Item
PET Scan 3 - Bolus injection Start time
time
C0032743 (UMLS CUI [1])
C1511237 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 3 - Duration of bolus injection
Item
PET Scan 3 - Duration of bolus injection
durationDatetime
C0032743 (UMLS CUI [1])
C1511237 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 3 - Constant infusion activity concentration (at start of infusion)
Item
PET Scan 3 - Constant infusion activity concentration (at start of infusion)
float
C0032743 (UMLS CUI [1])
C0574032 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 3 - Constant infusion start time
Item
PET Scan 3 - Constant infusion start time
time
C0032743 (UMLS CUI [1])
C0574032 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 3 - Constant infusion stop time
Item
PET Scan 3 - Constant infusion stop time
time
C0032743 (UMLS CUI [1])
C0574032 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
PET Scan 3 - Volume of constant infusion administered
Item
PET Scan 3 - Volume of constant infusion administered
float
C0032743 (UMLS CUI [1])
C0574032 (UMLS CUI [2,1])
C0449468 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
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