ID

30164

Descrizione

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: Liver Event

collegamento

https://clinicaltrials.gov/ct2/show/NCT01036061

Keywords

versioni (1)
  1. 16/05/18 16/05/18 -
Titolare del copyright

GlaxoSmithKline

Caricato su

16 maggio 2018

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Liver Event

1 moduli  
  1. StudyEvent: ODM
    1. Liver Event
Date of Visit
Descrizione

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit/Assessment
Descrizione

Date of Visit/Assessment

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
Liver events
Descrizione

Liver events

Alias
UMLS CUI-1
C1556667
Is this liver event a serious adverse event?
Descrizione

liver event a serious adverse event

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1556667
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/interruption criteria? Check all that apply
Descrizione

liver chemistry result

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
Is the subject age 55 or older?
Descrizione

age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
If female, is the subject pregnant?
Descrizione

If Yes, ensure Pregnancy Notification Form has been completed.

Tipo di dati

integer

Alias
UMLS CUI [1]
C0032961
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Descrizione

diagnostic imaging tests of the liver or hepatobiliary system

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C1711359
If Yes, were the results normal?
Descrizione

If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1274040
Were any liver biopsies performed?
Descrizione

If Yes, complete Liver Biopsy form.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0193388
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Descrizione

If Yes, record on the appropriate Concomitant Medication form.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0002346
UMLS CUI [2]
C0242295
UMLS CUI [3]
C0281875
Did the subject fast or undergo significant dietary change in the past week?
Descrizione

fasting or significant dietary change

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3671772
UMLS CUI [2]
C0015663
Liver Event - Investigational Product (Liver)
Descrizione

Liver Event - Investigational Product (Liver)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
UMLS CUI-3
C1556667
When did the liver event occur?
Descrizione

liver event timepoint

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1556667
UMLS CUI [1,2]
C2348792
start date of investigational product for that treatment period
Descrizione

If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
stop date of investigational product for that treatment period
Descrizione

If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
start date of investigational product for the most recent period prior to the liver event
Descrizione

If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
stop date of investigational product for the most recent period prior to the liver event
Descrizione

If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Liver Event - Pharmacokinetics
Descrizione

Liver Event - Pharmacokinetics

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C1556667
Was a pharmacokinetic blood sample obtained?
Descrizione

An unscheduled PK sample must be obtained within < insert time interval recommended by Clinical pharmacokinetics representative > of last dose

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
If Yes, date sample taken
Descrizione

Date sample taken

Tipo di dati

date

Alias
UMLS CUI [1]
C1302413
If Yes, time sample taken
Descrizione

Time sample taken

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0040223
If Yes, date of last investigational product dose prior to PK sample
Descrizione

Date of last investigational product dose

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
If Yes, time of last investigational product dose prior to PK sample
Descrizione

Time of last investigational product dose

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C0040223
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Similar models

Liver Event

1 moduli
  1. StudyEvent: ODM
    1. Liver Event
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Item Group
Liver events
C1556667 (UMLS CUI-1)
Item
Is this liver event a serious adverse event?
integer
C1519255 (UMLS CUI [1,1])
C1556667 (UMLS CUI [1,2])
liver event a serious adverse event
Code List
Is this liver event a serious adverse event?
CL Item
Yes, Please complete liver event forms and serious adverse event form (1)
CL Item
No (2)
Item
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/interruption criteria? Check all that apply
integer
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
liver chemistry result
Code List
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/interruption criteria? Check all that apply
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspartate aminotraasferase) (2)
CL Item
Total bilirunbin  (3)
CL Item
Alkaline phosphatase (4)
CL Item
5" nucleotidase (5)
CL Item
Gammaglutamyltranspeptidase (6)
CL Item
Other (7)
age
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
If female, is the subject pregnant?
integer
C0032961 (UMLS CUI [1])
If female, is the subject pregnant?
Code List
If female, is the subject pregnant?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
diagnostic imaging tests of the liver or hepatobiliary system
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C1711359 (UMLS CUI [1,3])
diagnostic imaging results
Item
If Yes, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
liver biopsies
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drug use
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C0002346 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
fasting or significant dietary change
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C3671772 (UMLS CUI [1])
C0015663 (UMLS CUI [2])
Item Group
Liver Event - Investigational Product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C1556667 (UMLS CUI-3)
Item
When did the liver event occur?
integer
C1556667 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
liver event timepoint
Code List
When did the liver event occur?
CL Item
During the treatment period (1)
CL Item
After the treatment period (2)
start date of investigational product
Item
start date of investigational product for that treatment period
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
stop date of investigational product
Item
stop date of investigational product for that treatment period
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
start date of investigational product
Item
start date of investigational product for the most recent period prior to the liver event
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
stop date of investigational product
Item
stop date of investigational product for the most recent period prior to the liver event
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Liver Event - Pharmacokinetics
C0031327 (UMLS CUI-1)
C1556667 (UMLS CUI-2)
pharmacokinetic blood sample
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Date sample taken
Item
If Yes, date sample taken
date
C1302413 (UMLS CUI [1])
Time sample taken
Item
If Yes, time sample taken
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of last investigational product dose
Item
If Yes, date of last investigational product dose prior to PK sample
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Time of last investigational product dose
Item
If Yes, time of last investigational product dose prior to PK sample
time
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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