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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00443170
Registration number
NCT00443170
Ethics application status
Date submitted
1/03/2007
Date registered
5/03/2007
Date last updated
19/03/2012
Titles & IDs
Public title
A Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects
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Scientific title
A Randomized, Blinded, Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Single and Repeat Dose Escalation of the Oral YAK3/DYRK3 Inhibitor GSK626616AC in Healthy Subjects
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Secondary ID [1]
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YAK106752
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects
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Anaemia
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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adverse events at end of each cohort
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Assessment method [1]
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Timepoint [1]
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end of each cohort
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Primary outcome [2]
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hematology/chemistry/urinalysis at end of each cohort
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Assessment method [2]
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Timepoint [2]
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end of each cohort
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Primary outcome [3]
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physical examination at end of each cohort
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Assessment method [3]
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Timepoint [3]
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end of each cohort
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Primary outcome [4]
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vital signs and electrocardiogram (ECG) at end of each cohort
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Assessment method [4]
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Timepoint [4]
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end of each cohort
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Secondary outcome [1]
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GSK626616 pharmacokinetics at end of each cohort
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Assessment method [1]
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Timepoint [1]
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end of each cohort
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Secondary outcome [2]
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hemoglobin at end of each cohort
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Assessment method [2]
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Timepoint [2]
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end of each cohort
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Secondary outcome [3]
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red blood cell measurements at end of each cohort
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Assessment method [3]
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Timepoint [3]
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end of each cohort
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Secondary outcome [4]
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estimates of CYP enzyme activity at end of study
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Assessment method [4]
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Timepoint [4]
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end of study
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Secondary outcome [5]
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mRNA levels in peripheral blood at end of study
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Assessment method [5]
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Timepoint [5]
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end of study
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Eligibility
Key inclusion criteria
* Age 18 to 55 years healthy subjects
* Hemoglobin values of 13.5-17.0 g/dL for males or 12.0-15.5 g/dL for females.
* Females cannot be pregnant.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Cannot have exposure to greater than 4 new chemical entities within 12 months.
* Cannot have a clinical history of current alcohol, or illicit drug use which, in the judgment of the Investigator, would interfere with the subject's ability to comply with the dosing schedule.
* Cannot have a history of regular use of tobacco- or nicotine-containing products within 3 months.
* Must not have received a blood transfusion or had a donation of blood within 3 months prior to study entry.
* Cannot use be taking prescription, non-prescription or illicit drugs.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
90
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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GSK Investigational Site - Randwick, Sydney
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Recruitment hospital [2]
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GSK Investigational Site - Herston
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Recruitment hospital [3]
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GSK Investigational Site - Adelaide
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Recruitment postcode(s) [1]
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2031 - Randwick, Sydney
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Recruitment postcode(s) [2]
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4006 - Herston
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a first time in human study to investigate the safety of GSK626616AC given as oral single and repeat doses in healthy subjects. An additional group of subjects will be assessed to determine the effect of several drugs given at the same time as GSK626616.
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Trial website
https://clinicaltrials.gov/study/NCT00443170
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00443170
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