ID
30164
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: Liver Event
Lien
https://clinicaltrials.gov/ct2/show/NCT01036061
Mots-clés
Versions (1)
- 16/05/2018 16/05/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
16 mai 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061
Liver Event
- StudyEvent: ODM
Description
Liver events
Alias
- UMLS CUI-1
- C1556667
Description
liver event a serious adverse event
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1556667
Description
liver chemistry result
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
Description
age
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
If Yes, ensure Pregnancy Notification Form has been completed.
Type de données
integer
Alias
- UMLS CUI [1]
- C0032961
Description
diagnostic imaging tests of the liver or hepatobiliary system
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C1711359
Description
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1274040
Description
If Yes, complete Liver Biopsy form.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0193388
Description
If Yes, record on the appropriate Concomitant Medication form.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0002346
- UMLS CUI [2]
- C0242295
- UMLS CUI [3]
- C0281875
Description
fasting or significant dietary change
Type de données
boolean
Alias
- UMLS CUI [1]
- C3671772
- UMLS CUI [2]
- C0015663
Description
Liver Event - Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C1556667
Description
liver event timepoint
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1556667
- UMLS CUI [1,2]
- C2348792
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
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.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
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.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
Liver Event - Pharmacokinetics
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C1556667
Description
An unscheduled PK sample must be obtained within < insert time interval recommended by Clinical pharmacokinetics representative > of last dose
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Description
Date sample taken
Type de données
date
Alias
- UMLS CUI [1]
- C1302413
Description
Time sample taken
Type de données
time
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0040223
Description
Date of last investigational product dose
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Description
Time of last investigational product dose
Type de données
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])