ID
30362
Beschrijving
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
Trefwoorden
Versies (1)
- 30-05-18 30-05-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
30 mei 2018
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Please fill out for PET RD Day 5, 6, 7, 8, 9, 10
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Beschrijving
Actual date of vital signs
Datatype
date
Alias
- UMLS CUI [1]
- C2826644
Beschrijving
Actual time of vital signs
Datatype
time
Alias
- UMLS CUI [1]
- C2826762
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Respiration rate
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
Temperature
Datatype
float
Maateenheden
- C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
ECG
Alias
- UMLS CUI-1
- C1623258
Beschrijving
Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) PET RD Day 3-10: 12-lead-ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C1623258
Beschrijving
Start Date ECG
Datatype
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0808070
Beschrijving
Start Time ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1301880
Beschrijving
Stop Date ECG
Datatype
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0806020
Beschrijving
Stop Time ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1522314
Beschrijving
Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Beschrijving
Haematology sampling date and time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beschrijving
Fasting
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015663
Beschrijving
Please answer the following questions for each Haematology Analyte
Datatype
integer
Alias
- UMLS CUI [1]
- C0018941
Beschrijving
Type of result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beschrijving
Haematology Numeric Result
Datatype
float
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2347373
Beschrijving
Haematology Character Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2350015
Beschrijving
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Beschrijving
Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschrijving
Fasting
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015663
Beschrijving
Please answer the following questions for each Clinical Chemistry Analyte
Datatype
integer
Alias
- UMLS CUI [1]
- C0008000
Beschrijving
Type of result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beschrijving
Clinical Chemistry Numeric Result
Datatype
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Beschrijving
Clinical Chemistry Character Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Beschrijving
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Beschrijving
Date sample taken
Datatype
date
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C1302413
Beschrijving
Time sample taken
Datatype
time
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C4064021
Beschrijving
Result of dipstick
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1160927
- UMLS CUI [1,2]
- C0587081
Beschrijving
If Yes, provide details of repeated tests in the add entry section below
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2700128
- UMLS CUI [1,2]
- C0587081
Beschrijving
Urinalysis - Local: Dipstick Details
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Beschrijving
Please answer the following questions for each Urinalysis Analyte
Datatype
integer
Alias
- UMLS CUI [1]
- C0042014
Beschrijving
Type of result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beschrijving
Urinalysis Numeric Result
Datatype
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2347373
Beschrijving
Urinalysis Character Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2350015
Beschrijving
Urinalysis - Local: Microscopy Details
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C0042014
Beschrijving
Please answer the following questions for each Urinalysis Analyte
Datatype
integer
Alias
- UMLS CUI [1]
- C0430397
Beschrijving
Type of result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beschrijving
Urinalysis Numeric Result
Datatype
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2347373
Beschrijving
Urinalysis Character Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2350015
Beschrijving
Questionnaires
Alias
- UMLS CUI-1
- C0034394
Beschrijving
Please fill out 3h after dosing
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0041755
- UMLS CUI [1,2]
- C0015371
- UMLS CUI [1,3]
- C0681889
Beschrijving
The Barnes Akathisia Scale Score
Datatype
integer
Alias
- UMLS CUI [1]
- C3541345
Beschrijving
Abnormal Involuntary Movement Scale Score
Datatype
integer
Alias
- UMLS CUI [1]
- C0450978
Beschrijving
Profile of Mood States
Datatype
text
Alias
- UMLS CUI [1]
- C0451394
Beschrijving
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])