ID
30362
Description
Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Visit Documentation 19 Specification: PET RD Day 3-Day 10
Link
https://clinicaltrials.gov/ct2/show/NCT01036061
Keywords
Versions (1)
- 5/30/18 5/30/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 30, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061
Visit Documentation 19
- StudyEvent: ODM
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Please fill out for PET RD Day 5, 6, 7, 8, 9, 10
Data type
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Description
Actual date of vital signs
Data type
date
Alias
- UMLS CUI [1]
- C2826644
Description
Actual time of vital signs
Data type
time
Alias
- UMLS CUI [1]
- C2826762
Description
Systolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Respiration rate
Data type
integer
Measurement units
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Temperature
Data type
float
Measurement units
- C
Alias
- UMLS CUI [1]
- C0005903
Description
ECG
Alias
- UMLS CUI-1
- C1623258
Description
Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) PET RD Day 3-10: 12-lead-ECG
Data type
integer
Alias
- UMLS CUI [1]
- C1623258
Description
Start Date ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0808070
Description
Start Time ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1301880
Description
Stop Date ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0806020
Description
Stop Time ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1522314
Description
Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Description
Haematology sampling date and time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Description
Fasting
Data type
boolean
Alias
- UMLS CUI [1]
- C0015663
Description
Please answer the following questions for each Haematology Analyte
Data type
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Type of result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Haematology Numeric Result
Data type
float
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2347373
Description
Haematology Character Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2350015
Description
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Description
Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Description
Fasting
Data type
boolean
Alias
- UMLS CUI [1]
- C0015663
Description
Please answer the following questions for each Clinical Chemistry Analyte
Data type
integer
Alias
- UMLS CUI [1]
- C0008000
Description
Type of result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Clinical Chemistry Numeric Result
Data type
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Description
Clinical Chemistry Character Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Description
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Description
Date sample taken
Data type
date
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C1302413
Description
Time sample taken
Data type
time
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C4064021
Description
Result of dipstick
Data type
integer
Alias
- UMLS CUI [1,1]
- C1160927
- UMLS CUI [1,2]
- C0587081
Description
If Yes, provide details of repeated tests in the add entry section below
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2700128
- UMLS CUI [1,2]
- C0587081
Description
Urinalysis - Local: Dipstick Details
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Description
Please answer the following questions for each Urinalysis Analyte
Data type
integer
Alias
- UMLS CUI [1]
- C0042014
Description
Type of result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Urinalysis Numeric Result
Data type
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2347373
Description
Urinalysis Character Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2350015
Description
Urinalysis - Local: Microscopy Details
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C0042014
Description
Please answer the following questions for each Urinalysis Analyte
Data type
integer
Alias
- UMLS CUI [1]
- C0430397
Description
Type of result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Urinalysis Numeric Result
Data type
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2347373
Description
Urinalysis Character Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2350015
Description
Questionnaires
Alias
- UMLS CUI-1
- C0034394
Description
Please fill out 3h after dosing
Data type
integer
Alias
- UMLS CUI [1,1]
- C0041755
- UMLS CUI [1,2]
- C0015371
- UMLS CUI [1,3]
- C0681889
Description
The Barnes Akathisia Scale Score
Data type
integer
Alias
- UMLS CUI [1]
- C3541345
Description
Abnormal Involuntary Movement Scale Score
Data type
integer
Alias
- UMLS CUI [1]
- C0450978
Description
Profile of Mood States
Data type
text
Alias
- UMLS CUI [1]
- C0451394
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
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Visit Documentation 19
- StudyEvent: ODM
C3641100 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C0518766 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
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C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
C4064021 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
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C0430370 (UMLS CUI-2)
(Comment:en)
C0430370 (UMLS CUI-2)
(Comment:en)
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0042014 (UMLS CUI-2)
C0430397 (UMLS CUI-3)
(Comment:en)
C0430397 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0430397 (UMLS CUI-2)
(Comment:en)
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0015371 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])