ID

30342

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: Visit Documentation 10 Specification: Cohort 1-4 RD Day- 9, 15, 16, 17, 23, 24

Lien

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

Mots-clés

Versions (1)
  1. 29/05/2018 29/05/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

29 mai 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

Anglais

Visit Documentation 10

1 Formulaires  
  1. StudyEvent: ODM
    1. Visit Documentation 10
Date and Type of Visit
Description

Date and Type of Visit

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C3641100
UMLS CUI-3
C0008976
Site
Description

Site

Type de données

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Type de données

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Description

Patient Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/Assessment
Description

Date of Visit/Assessment

Type de données

date

Alias
UMLS CUI [1]
C1320303
Time of Visit
Description

Time of Visit

Type de données

time

Alias
UMLS CUI [1]
C1320304
Cohort
Description

Cohort

Type de données

integer

Alias
UMLS CUI [1]
C0599755
Type of Visit
Description

Please choose the type of visit/form you would like to answer, for example Cohort 1-4 SD Day 1

Type de données

integer

Alias
UMLS CUI [1,1]
C3641100
UMLS CUI [1,2]
C0008976
ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
Type of ECG
Description

Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) Cohort 1-4 RD Day 9, 15, 16, 17, 23, 24: 12-lead ECG

Type de données

integer

Alias
UMLS CUI [1]
C1623258
Time from last dose of investigational product until ECG
Description

Time from last dose of investigational product until ECG

Type de données

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2348792
Start Date ECG
Description

Start Date ECG

Type de données

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0808070
Start Time ECG
Description

Start Time ECG

Type de données

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1301880
Stop Date ECG
Description

Stop Date ECG

Type de données

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0806020
Stop Time ECG
Description

Stop Time ECG

Type de données

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1522314
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Date of dose
Description

Date of dose

Type de données

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
Time of dose
Description

Time of dose

Type de données

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Pharmacokinetics Blood
Description

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
Time from last dose of investigational product until Clinical Chemistry measurement
Description

Time from last dose of investigational product until Clinical Chemistry measurement

Type de données

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
Actual Time of Pharmacokinetics Blood
Description

Actual Time of Pharmacokinetics Blood

Type de données

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
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Similar models

Visit Documentation 10

1 Formulaires
  1. StudyEvent: ODM
    1. Visit Documentation 10
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Date and Type of Visit
C1320303 (UMLS CUI-1)
C3641100 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Time of Visit
Item
Time of Visit
time
C1320304 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
Cohort 1 (1)
CL Item
Cohort 2 (2)
CL Item
Cohort 3 (3)
CL Item
Cohort 4 (4)
CL Item
PET (5)
Item
Type of Visit
integer
C3641100 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Type of Visit
Code List
Type of Visit
CL Item
Cohort 1-4 RD Day 9 (1)
CL Item
Cohort 1-4 RD Day 15 (2)
CL Item
Cohort 1-4 RD Day 16 (3)
CL Item
Cohort 1-4 RD Day 17 (4)
CL Item
Cohort 1-4 RD Day 23 (5)
CL Item
Cohort 1-4 RD Day 24 (6)
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
Type of ECG
integer
C1623258 (UMLS CUI [1])
Type of ECG
Code List
Type of ECG
CL Item
12 lead ECG (1)
Item
Time from last dose of investigational product until ECG
integer
C1623258 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Timepoint of ECG
Code List
Time from last dose of investigational product until ECG
CL Item
Pre-dose 1 (1)
CL Item
Pre-dose 2 (2)
CL Item
Pre-dose 3 (3)
CL Item
1h (4)
CL Item
2h (5)
CL Item
4h (6)
CL Item
8h (7)
CL Item
12h (8)
CL Item
24h (9)
CL Item
36h (10)
Start Date ECG
Item
Start Date ECG
date
C1623258 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time ECG
Item
Start Time ECG
time
C1623258 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop Date ECG
Item
Stop Date ECG
date
C1623258 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Time ECG
Item
Stop Time ECG
time
C1623258 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Pharmacokinetics Blood
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Time from last dose of investigational product until Clinical Chemistry measurement
integer
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
Timepoint of Laboratory Procedure
Code List
Time from last dose of investigational product until Clinical Chemistry measurement
CL Item
Predose (1)
Actual Time of Pharmacokinetics Blood
Item
Actual Time of Pharmacokinetics Blood
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Retour au début de la page 

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