ID
30164
Descripción
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
Link
https://clinicaltrials.gov/ct2/show/NCT01036061
Palabras clave
Versiones (1)
- 16/5/18 16/5/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
16 de mayo de 2018
DOI
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Licencia
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
Liver Event
- StudyEvent: ODM
Descripción
Liver events
Alias
- UMLS CUI-1
- C1556667
Descripción
liver event a serious adverse event
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1556667
Descripción
liver chemistry result
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
Descripción
age
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0001779
Descripción
If Yes, ensure Pregnancy Notification Form has been completed.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0032961
Descripción
diagnostic imaging tests of the liver or hepatobiliary system
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C1711359
Descripción
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1274040
Descripción
If Yes, complete Liver Biopsy form.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0193388
Descripción
If Yes, record on the appropriate Concomitant Medication form.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0002346
- UMLS CUI [2]
- C0242295
- UMLS CUI [3]
- C0281875
Descripción
fasting or significant dietary change
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3671772
- UMLS CUI [2]
- C0015663
Descripción
Liver Event - Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C1556667
Descripción
liver event timepoint
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1556667
- UMLS CUI [1,2]
- C2348792
Descripción
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Descripción
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Descripción
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 de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Descripción
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 de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Descripción
Liver Event - Pharmacokinetics
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C1556667
Descripción
An unscheduled PK sample must be obtained within < insert time interval recommended by Clinical pharmacokinetics representative > of last dose
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Descripción
Date sample taken
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302413
Descripción
Time sample taken
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0040223
Descripción
Date of last investigational product dose
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Descripción
Time of last investigational product dose
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [1,3]
- C0040223
Similar models
Liver Event
- StudyEvent: ODM
C1556667 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,2])
C1711359 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0242295 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
C0015663 (UMLS CUI [2])
C0023884 (UMLS CUI-2)
C1556667 (UMLS CUI-3)
C2348792 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1556667 (UMLS CUI-2)
C0031328 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])