ID
29969
Beschreibung
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
Link
https://clinicaltrials.gov/ct2/show/NCT01036061
Stichworte
Versionen (2)
- 24.04.18 24.04.18 -
- 30.04.18 30.04.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
30. April 2018
DOI
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Lizenz
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
Beschreibung
Cohort
Alias
- UMLS CUI-1
- C0599755
- UMLS CUI-2
- C0008976
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Date of Birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Childbearing potential
Datentyp
integer
Alias
- UMLS CUI [1]
- C3831118
Beschreibung
Ethnicity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
African American/African Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Beschreibung
American Indian or Alaskan Native
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1515945
Beschreibung
Asian - Central/South Asian Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Beschreibung
Asian - East Asian Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0003983
Beschreibung
Japanese Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1556094
Beschreibung
South East Asian Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0238697
Beschreibung
Hawaiian or Other Pacific Islander
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1513907
Beschreibung
White - Arabic/North African Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C0026068
Beschreibung
White - White/Caucasian!European Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0043157
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Actual date of vital signs
Datentyp
date
Alias
- UMLS CUI [1]
- C2826644
Beschreibung
Actual time of vital signs
Datentyp
time
Alias
- UMLS CUI [1]
- C2826762
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Body mass index
Datentyp
float
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
Position
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Beschreibung
Systolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Respiration rate
Datentyp
integer
Maßeinheiten
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschreibung
Temperature
Datentyp
float
Maßeinheiten
- C
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
12-lead ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1623258
- UMLS CUI-3
- C0031809
Beschreibung
Start Date of ECG
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beschreibung
Start Time of ECG
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschreibung
Heart Rate
Datentyp
integer
Maßeinheiten
- Beats/min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0430456
Beschreibung
PR Interval
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0429087
- UMLS CUI [1,2]
- C0430456
Beschreibung
QRS Duration
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0429025
- UMLS CUI [1,2]
- C0430456
Beschreibung
Uncorrected QT Interval
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C0430456
Beschreibung
Method of QTC Measurement
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C1299991
Beschreibung
QTcB
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C0855331
Beschreibung
QTcF
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C1882513
- UMLS CUI [1,2]
- C0855331
Beschreibung
RR interval
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0430456
Beschreibung
(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)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C0430456
Beschreibung
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Beschreibung
Menstrual cycle profile
Alias
- UMLS CUI-1
- C0025329
Beschreibung
Date of start of last menstrual period
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0808070
Beschreibung
Date of end of last menstrual period
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0806020
Beschreibung
Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Beschreibung
Day Month Year Hr : Min (00:00 - 23:59)
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beschreibung
Fasting
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015663
Beschreibung
Please answer the following questions for each Haematology Analyte
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beschreibung
Type of result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beschreibung
Haematology Numeric Result
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2347373
Beschreibung
Haematology Character Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2350015
Beschreibung
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Beschreibung
Date and time sample taken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschreibung
Fasting
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015663
Beschreibung
Please answer the following questions for each Clinical Chemistry Analyte
Datentyp
integer
Alias
- UMLS CUI [1]
- C0008000
Beschreibung
Type of result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beschreibung
Clinical Chemistry Numeric Result
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Beschreibung
Clinical Chemistry Character Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Beschreibung
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Beschreibung
Date sample taken
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C1302413
Beschreibung
Time sample taken
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C4064021
Beschreibung
If positive, record results of individual tests below.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1160927
- UMLS CUI [1,2]
- C0587081
Beschreibung
If Yes, provide details on the MICROSCOPY form
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2700128
- UMLS CUI [1,2]
- C0587081
Beschreibung
Urinalysis - Local: Dipstick Details
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Beschreibung
Please answer the following questions for each Urinalysis Analyte
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042014
Beschreibung
Type of result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beschreibung
Urinalysis Numeric Result
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2347373
Beschreibung
Urinalysis Character Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2350015
Beschreibung
Urinalysis - Local: Microscopy Details
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C0042014
Beschreibung
Please answer the following questions for each Urinalysis Analyte
Datentyp
integer
Beschreibung
Type of result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beschreibung
Urinalysis Numeric Result
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2347373
Beschreibung
Urinalysis Character Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2350015
Beschreibung
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0022885
Beschreibung
Date and time sample taken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschreibung
Fasting
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015663
Beschreibung
Please answer the following questions for each Clinical Chemistry Analyte
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0022885
Beschreibung
Type of result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beschreibung
Clinical Chemistry Numeric Result
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Beschreibung
Clinical Chemistry Character Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Beschreibung
Columbia Suicide Rating scale
Alias
- UMLS CUI-1
- C3888485
Beschreibung
Randomisation
Alias
- UMLS CUI-1
- C0034656
Beschreibung
Randomisation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C2348568
Beschreibung
Randomisation number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
Date of randomisation
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
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)
(Comment:en)
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(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)
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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])