ID

37507

Description

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

Keywords

Versions (2)
  1. 7/24/19 7/24/19 -
  2. 8/4/19 8/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 4, 2019

DOI

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License

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

English

Day -1 - PET; Functional MRI Scan

1 forms  
Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Description

Date of Visit

Data type

date

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

PET - Scan 2

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

Date of PET Scan 2

Data type

date

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

PET Scan 2 - Examination Number

Data type

integer

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

PET Scan 2 - Radiochemical purity at release

Data type

integer

Measurement units
  • %
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
Description

PET Scan 2 - Radiochemical purity time at release

Data type

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
Description

PET Scan 2 - Mass of tracer administered

Data type

float

Measurement units
  • 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)
Description

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

Data type

float

Measurement units
  • 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
Description

PET Scan 2 - Bolus activity injected

Data type

float

Measurement units
  • 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
Description

PET Scan 2 - Bolus injection Start time

Data type

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
Description

PET Scan 2 - Duration of bolus injection

Data type

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)
Description

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

Data type

float

Measurement units
  • 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
Description

PET Scan 2 - Constant infusion start time

Data type

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
Description

PET Scan 2 - Constant infusion stop time

Data type

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
Description

PET Scan 2 - Volume of constant infusion administered

Data type

float

Measurement units
  • 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
Description

Functional MRI Scan

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

Has an fMRI scan been carried out?

Data type

boolean

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

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

Data type

date

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

fMRI Examination Number

Data type

integer

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

fMRI Scan start time

Data type

time

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

fMRI Scan end time

Data type

time

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

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

Data type

text

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

PET - Scan 3

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

Date of PET Scan 3

Data type

date

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

PET Scan 3 - Examination Number

Data type

integer

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

PET Scan 3 - Radiochemical purity at release

Data type

integer

Measurement units
  • %
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
Description

PET Scan 3 - Radiochemical purity time at release

Data type

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
Description

PET Scan 3 - Mass of tracer administered

Data type

float

Measurement units
  • 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)
Description

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

Data type

float

Measurement units
  • 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
Description

PET Scan 3 - Bolus activity injected

Data type

float

Measurement units
  • 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
Description

PET Scan 3 - Bolus injection Start time

Data type

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
Description

PET Scan 3 - Duration of bolus injection

Data type

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)
Description

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

Data type

float

Measurement units
  • 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
Description

PET Scan 3 - Constant infusion start time

Data type

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
Description

PET Scan 3 - Constant infusion stop time

Data type

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
Description

PET Scan 3 - Volume of constant infusion administered

Data type

float

Measurement units
  • 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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Similar models

Day -1 - PET; Functional MRI Scan

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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