ID
30349
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 13 Specification: Cohort 1-4 RD Day-11, 12, 18, 19
Link
https://clinicaltrials.gov/ct2/show/NCT01036061
Keywords
Versions (1)
- 5/29/18 5/29/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 29, 2018
DOI
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License
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
Visit Documentation 13
- StudyEvent: ODM
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Time from last dose of investigational product until Vital Signs measurement
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
- UMLS CUI [1,3]
- C0518766
Description
In semisupine position
Data type
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Description
Actual date of vital signs
Data type
date
Alias
- UMLS CUI [1]
- C2826644
Description
Actual time of vital signs
Data type
time
Alias
- UMLS CUI [1]
- C2826762
Description
Systolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Respiration rate
Data type
integer
Measurement units
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Temperature
Data type
float
Measurement units
- C
Alias
- UMLS CUI [1]
- C0005903
Description
ECG
Alias
- UMLS CUI-1
- C1623258
Description
Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) Cohort 1-4 RD Day-11, 12, 18, 19: 12-lead-ECG
Data type
integer
Alias
- UMLS CUI [1]
- C1623258
Description
Start Date ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0808070
Description
Start Time ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1301880
Description
Stop Date ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0806020
Description
Stop Time ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1522314
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
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Visit Documentation 13
- StudyEvent: ODM
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C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
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