ID
30362
Beskrivning
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
Länk
https://clinicaltrials.gov/ct2/show/NCT01036061
Nyckelord
Versioner (1)
- 2018-05-30 2018-05-30 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
30 maj 2018
DOI
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Licens
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
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Please fill out for PET RD Day 5, 6, 7, 8, 9, 10
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Beskrivning
Actual date of vital signs
Datatyp
date
Alias
- UMLS CUI [1]
- C2826644
Beskrivning
Actual time of vital signs
Datatyp
time
Alias
- UMLS CUI [1]
- C2826762
Beskrivning
Systolic Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Respiration rate
Datatyp
integer
Måttenheter
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beskrivning
Temperature
Datatyp
float
Måttenheter
- C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
ECG
Alias
- UMLS CUI-1
- C1623258
Beskrivning
Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) PET RD Day 3-10: 12-lead-ECG
Datatyp
integer
Alias
- UMLS CUI [1]
- C1623258
Beskrivning
Start Date ECG
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0808070
Beskrivning
Start Time ECG
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1301880
Beskrivning
Stop Date ECG
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0806020
Beskrivning
Stop Time ECG
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1522314
Beskrivning
Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Beskrivning
Haematology sampling date and time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beskrivning
Fasting
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015663
Beskrivning
Please answer the following questions for each Haematology Analyte
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beskrivning
Type of result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beskrivning
Haematology Numeric Result
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2347373
Beskrivning
Haematology Character Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2350015
Beskrivning
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Beskrivning
Date and time sample taken
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beskrivning
Fasting
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015663
Beskrivning
Please answer the following questions for each Clinical Chemistry Analyte
Datatyp
integer
Alias
- UMLS CUI [1]
- C0008000
Beskrivning
Type of result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beskrivning
Clinical Chemistry Numeric Result
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Beskrivning
Clinical Chemistry Character Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Beskrivning
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Beskrivning
Date sample taken
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C1302413
Beskrivning
Time sample taken
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C4064021
Beskrivning
Result of dipstick
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1160927
- UMLS CUI [1,2]
- C0587081
Beskrivning
If Yes, provide details of repeated tests in the add entry section below
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2700128
- UMLS CUI [1,2]
- C0587081
Beskrivning
Urinalysis - Local: Dipstick Details
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Beskrivning
Please answer the following questions for each Urinalysis Analyte
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042014
Beskrivning
Type of result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beskrivning
Urinalysis Numeric Result
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2347373
Beskrivning
Urinalysis Character Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2350015
Beskrivning
Urinalysis - Local: Microscopy Details
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C0042014
Beskrivning
Please answer the following questions for each Urinalysis Analyte
Datatyp
integer
Alias
- UMLS CUI [1]
- C0430397
Beskrivning
Type of result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beskrivning
Urinalysis Numeric Result
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2347373
Beskrivning
Urinalysis Character Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2350015
Beskrivning
Questionnaires
Alias
- UMLS CUI-1
- C0034394
Beskrivning
Please fill out 3h after dosing
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0041755
- UMLS CUI [1,2]
- C0015371
- UMLS CUI [1,3]
- C0681889
Beskrivning
The Barnes Akathisia Scale Score
Datatyp
integer
Alias
- UMLS CUI [1]
- C3541345
Beskrivning
Abnormal Involuntary Movement Scale Score
Datatyp
integer
Alias
- UMLS CUI [1]
- C0450978
Beskrivning
Profile of Mood States
Datatyp
text
Alias
- UMLS CUI [1]
- C0451394
Beskrivning
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Similar models
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)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
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])