ID
29969
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: Screening
Lien
https://clinicaltrials.gov/ct2/show/NCT01036061
Mots-clés
Versions (2)
- 24/04/2018 24/04/2018 -
- 30/04/2018 30/04/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
30 avril 2018
DOI
Pour une demande vous connecter.
Licence
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
Screening
- StudyEvent: ODM
Description
Cohort
Alias
- UMLS CUI-1
- C0599755
- UMLS CUI-2
- C0008976
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of Birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Type de données
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Childbearing potential
Type de données
integer
Alias
- UMLS CUI [1]
- C3831118
Description
Ethnicity
Type de données
integer
Alias
- UMLS CUI [1]
- C0015031
Description
African American/African Heritage
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Description
American Indian or Alaskan Native
Type de données
boolean
Alias
- UMLS CUI [1]
- C1515945
Description
Asian - Central/South Asian Heritage
Type de données
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Description
Asian - East Asian Heritage
Type de données
boolean
Alias
- UMLS CUI [1]
- C0003983
Description
Japanese Heritage
Type de données
boolean
Alias
- UMLS CUI [1]
- C1556094
Description
South East Asian Heritage
Type de données
boolean
Alias
- UMLS CUI [1]
- C0238697
Description
Hawaiian or Other Pacific Islander
Type de données
boolean
Alias
- UMLS CUI [1]
- C1513907
Description
White - Arabic/North African Heritage
Type de données
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C0026068
Description
White - White/Caucasian!European Heritage
Type de données
boolean
Alias
- UMLS CUI [1]
- C0043157
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Actual date of vital signs
Type de données
date
Alias
- UMLS CUI [1]
- C2826644
Description
Actual time of vital signs
Type de données
time
Alias
- UMLS CUI [1]
- C2826762
Description
Height
Type de données
integer
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body mass index
Type de données
float
Alias
- UMLS CUI [1]
- C1305855
Description
Position
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Description
Systolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Respiration rate
Type de données
integer
Unités de mesure
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Temperature
Type de données
float
Unités de mesure
- C
Alias
- UMLS CUI [1]
- C0005903
Description
12-lead ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1623258
- UMLS CUI-3
- C0031809
Description
Start Date of ECG
Type de données
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Description
Start Time of ECG
Type de données
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Description
Heart Rate
Type de données
integer
Unités de mesure
- Beats/min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0430456
Description
PR Interval
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0429087
- UMLS CUI [1,2]
- C0430456
Description
QRS Duration
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0429025
- UMLS CUI [1,2]
- C0430456
Description
Uncorrected QT Interval
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C0430456
Description
Method of QTC Measurement
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C1299991
Description
QTcB
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C0855331
Description
QTcF
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C1882513
- UMLS CUI [1,2]
- C0855331
Description
RR interval
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0430456
Description
(complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE)
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C0430456
Description
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Description
Menstrual cycle profile
Alias
- UMLS CUI-1
- C0025329
Description
Date of start of last menstrual period
Type de données
date
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0808070
Description
Date of end of last menstrual period
Type de données
date
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0806020
Description
Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Description
Day Month Year Hr : Min (00:00 - 23:59)
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Description
Fasting
Type de données
boolean
Alias
- UMLS CUI [1]
- C0015663
Description
Please answer the following questions for each Haematology Analyte
Type de données
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Type of result
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Haematology Numeric Result
Type de données
float
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2347373
Description
Haematology Character Result
Type de données
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
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Description
Fasting
Type de données
boolean
Alias
- UMLS CUI [1]
- C0015663
Description
Please answer the following questions for each Clinical Chemistry Analyte
Type de données
integer
Alias
- UMLS CUI [1]
- C0008000
Description
Type of result
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Clinical Chemistry Numeric Result
Type de données
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Description
Clinical Chemistry Character Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Description
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Description
Date sample taken
Type de données
date
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C1302413
Description
Time sample taken
Type de données
time
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C4064021
Description
If positive, record results of individual tests below.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1160927
- UMLS CUI [1,2]
- C0587081
Description
If Yes, provide details on the MICROSCOPY form
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C0042014
Description
Type of result
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Urinalysis Numeric Result
Type de données
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2347373
Description
Urinalysis Character Result
Type de données
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
Type de données
integer
Description
Type of result
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Urinalysis Numeric Result
Type de données
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2347373
Description
Urinalysis Character Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2350015
Description
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0022885
Description
Date and time sample taken
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Description
Fasting
Type de données
boolean
Alias
- UMLS CUI [1]
- C0015663
Description
Please answer the following questions for each Clinical Chemistry Analyte
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0022885
Description
Type of result
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Clinical Chemistry Numeric Result
Type de données
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Description
Clinical Chemistry Character Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Description
Columbia Suicide Rating scale
Alias
- UMLS CUI-1
- C3888485
Description
Randomisation
Alias
- UMLS CUI-1
- C0034656
Description
Randomisation
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C2348568
Description
Randomisation number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
Date of randomisation
Type de données
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Similar models
Screening
- StudyEvent: ODM
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C0026068 (UMLS CUI [2])
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C1299991 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (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)
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C0430370 (UMLS CUI-2)
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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)
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C0430397 (UMLS CUI-2)
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C0430397 (UMLS CUI-2)
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C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0022885 (UMLS CUI-2)
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
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C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])