A Single Centre Two Part Randomized Phase I Study to Assess the Pharmacokinetics of an ER Formulation of AZD2516 and to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 After Multiple Ascending Doses in Healthy Volunteers
Sponsor study identifier
interventional
6
1 country
1
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
July 2010
Actual (reported)AZD2516 is being developed for the oral treatment of chronic neuropathic pain. This study is split in to two parts. Part A will measure the effect of food and a new formulation of the drug in the blood and see how well it is tolerated. Part B will commence after the completion of Part A and will investigate the safety and tolerability of daily dosing with AZD2516.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 18, 2010
Actual (reported)June 22, 2010
Actual (reported)July 2010
Actual (reported)July 2010
Actual (reported)Adverse Events, vital signs
Day -1 until follow-up
Maximum plasma concentration (Cmax)
Day 1 - Day 12
Time to Cmax (tmax)
Day 1 - Day 12
Terminal rate constant (λz)
Day 1 - Day 12
AZD2516 (dose escalating)
Placebo
Oral, single, daily, 11 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Research Site
London, United Kingdom
Darren Wilbraham, MBBS, DCPSA
Quintiles Drug Research Unit 6, Newcomen Street, London, SE1 1YR
6 participants (actual enrollment reported by the registry).
First Submitted
June 18, 2010
First Posted
June 22, 2010
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2010
Actual (reported)Study Completion
July 2010
Actual (reported)Last Updated
February 8, 2011
Record last verified: 2011-02
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Source: ClinicalTrials.gov.
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