ID

36947

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. 6/23/19 6/23/19 -
  2. 8/4/19 8/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 23, 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 (NCT 00814957)

English

Screen - Inform Screening; Inform Enrolment; Date of visit; Demography; Vitals Signs

1 forms  
Inform Screening
Description

Inform Screening

Alias
UMLS CUI-1
C1710477
Subject initials
Description

Subject initials

Data type

integer

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Inform Enrolment
Description

Inform Enrolment

Alias
UMLS CUI-1
C1552002
UMLS CUI-2
C4041024
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date bf birth
Description

Date bf birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry
Description

Geographic ancestry

Data type

integer

Alias
UMLS CUI [1]
C3841890
Vital Signs - Measurement 1 Semi-Supine
Description

Vital Signs - Measurement 1 Semi-Supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0242485
UMLS CUI-3
C0522019
Vital Signs - Actual date/time
Description

Vital Signs - Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C2826644
UMLS CUI [1,2]
C2826762
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Data type

float

Alias
UMLS CUI [1]
C1305855
Systolic Blood pressure - semi supine
Description

Systolic Blood pressure - semi supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Heart rate - semi supine
Description

Heart rate - semi supine

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
beats/min
Respiration rate semi supine
Description

Respiration rate semi supine

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1,1]
C0231832
UMLS CUI [1,2]
C0522019
breaths/min
Vital Signs - Measurement 1 Standing
Description

Vital Signs - Measurement 1 Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0242485
UMLS CUI-3
C0231472
Vital signs - actual time
Description

Vital signs - actual time

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure - standing
Description

Systolic Blood Pressure - standing

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mm[Hg]
Diastolic Blood Pressure - standing
Description

Diastolic Blood Pressure - standing

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mm[Hg]
Heart rate - standing
Description

Heart rate - standing

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C2029905
beats/min
Vital Signs - Measurement 2 Semi-Supine
Description

Vital Signs - Measurement 2 Semi-Supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0242485
UMLS CUI-3
C0522019
Vital Signs - Actual time
Description

Vital Signs - Actual time

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood pressure semi supine
Description

Systolic Blood pressure semi supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Diastolic Blood Pressure semi supine
Description

Diastolic Blood Pressure semi supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
mm[Hg]
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Heart rate semi-supine
Description

Heart rate semi-supine

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
beats/min
Respiration rate semi supine
Description

Respiration rate semi supine

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1,1]
C0231832
UMLS CUI [1,2]
C0522019
breaths/min
Vital Signs - Measurement 2 Standing
Description

Vital Signs - Measurement 2 Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0242485
UMLS CUI-3
C0231472
Vital signs - actual time
Description

Vital signs - actual time

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure - standing
Description

Systolic Blood Pressure - standing

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mm[Hg]
Diastolic Blood Pressure - standing
Description

Diastolic Blood Pressure - standing

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mm[Hg]
Heart rate - standing
Description

Heart rate - standing

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C2029905
beats/min
Vital Signs - Measurement 3 Semi-Supine
Description

Vital Signs - Measurement 3 Semi-Supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0242485
UMLS CUI-3
C0522019
Vital Signs - Actual time
Description

Vital Signs - Actual time

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood pressure semi supine
Description

Systolic Blood pressure semi supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Diastolic Blood Pressure semi supine
Description

Diastolic Blood Pressure semi supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
mm[Hg]
Heart rate semi-supine
Description

Heart rate semi-supine

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
beats/min
Respiration rate semi supine
Description

Respiration rate semi supine

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1,1]
C0231832
UMLS CUI [1,2]
C0522019
breaths/min
Vital Signs - Measurement 3 Standing
Description

Vital Signs - Measurement 3 Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0242485
UMLS CUI-3
C0231472
Vital signs - actual time
Description

Vital signs - actual time

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure - standing
Description

Systolic Blood Pressure - standing

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mm[Hg]
Diastolic Blood Pressure - standing
Description

Diastolic Blood Pressure - standing

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mm[Hg]
Heart rate - standing
Description

Heart rate - standing

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C2029905
beats/min
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Similar models

Screen - Inform Screening; Inform Enrolment; Date of visit; Demography; Vitals Signs

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inform Screening
C1710477 (UMLS CUI-1)
Subject initials
Item
Subject initials
integer
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item Group
Inform Enrolment
C1552002 (UMLS CUI-1)
C4041024 (UMLS CUI-2)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date bf birth
Item
Date bf birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic ancestry
integer
C3841890 (UMLS CUI [1])
Geographic ancestry
Code List
Geographic ancestry
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Vital Signs - Measurement 1 Semi-Supine
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0522019 (UMLS CUI-3)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C2826644 (UMLS CUI [1,1])
C2826762 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Systolic Blood pressure - semi supine
Item
Systolic Blood pressure - semi supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Heart rate - semi supine
Item
Heart rate - semi supine
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Respiration rate semi supine
Item
Respiration rate semi supine
integer
C0231832 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Item Group
Vital Signs - Measurement 1 Standing
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
Vital signs - actual time
Item
Vital signs - actual time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure - standing
Item
Systolic Blood Pressure - standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic Blood Pressure - standing
Item
Diastolic Blood Pressure - standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Heart rate - standing
Item
Heart rate - standing
integer
C2029905 (UMLS CUI [1])
Item Group
Vital Signs - Measurement 2 Semi-Supine
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0522019 (UMLS CUI-3)
Vital Signs - Actual time
Item
Vital Signs - Actual time
time
C2826762 (UMLS CUI [1])
Systolic Blood pressure semi supine
Item
Systolic Blood pressure semi supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure semi supine
Item
Diastolic Blood Pressure semi supine
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Heart rate semi-supine
Item
Heart rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Respiration rate semi supine
Item
Respiration rate semi supine
integer
C0231832 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Item Group
Vital Signs - Measurement 2 Standing
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
Vital signs - actual time
Item
Vital signs - actual time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure - standing
Item
Systolic Blood Pressure - standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic Blood Pressure - standing
Item
Diastolic Blood Pressure - standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Heart rate - standing
Item
Heart rate - standing
integer
C2029905 (UMLS CUI [1])
Item Group
Vital Signs - Measurement 3 Semi-Supine
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0522019 (UMLS CUI-3)
Vital Signs - Actual time
Item
Vital Signs - Actual time
time
C2826762 (UMLS CUI [1])
Systolic Blood pressure semi supine
Item
Systolic Blood pressure semi supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure semi supine
Item
Diastolic Blood Pressure semi supine
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Heart rate semi-supine
Item
Heart rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Respiration rate semi supine
Item
Respiration rate semi supine
integer
C0231832 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Item Group
Vital Signs - Measurement 3 Standing
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
Vital signs - actual time
Item
Vital signs - actual time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure - standing
Item
Systolic Blood Pressure - standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic Blood Pressure - standing
Item
Diastolic Blood Pressure - standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Heart rate - standing
Item
Heart rate - standing
integer
C2029905 (UMLS CUI [1])
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