A MAD Study of ASP9226 in Healthy Subjects (Version 1)
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled multiple ascending dose study to assess safety, tolerability and pharmacokinetics of ASP9226 in healthy young and elderly male and female subjects
IRAS ID
130791
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Astellas Pharma Global Development Europe
Eudract number
2013-000109-21
Research summary
The new medicine tested in this study is a compound called ASP9226. ASP9226 is being developed for treating, among others, peripheral neuropathic pain (from damage to the nervous system), post-operative pain and potential visceral pain (from injured internal organs).
The main purpose of this study is to see how safe ASP9226 is and how well it is tolerated after dosing. The study will also investigate how ASP9226 is taken up, metabolized (chemically broken down), distributed through the body and excreted.
The study will be performed at the PAREXEL Early Phase Clinical Unit in the UK (Harrow).
Healthy, young males and females (module 1) and elderly males and females (module 2)will be included in this clinical study.
Sixty subjects will take part in the study. Module 1 will include 4 dose levels with 12 subjects per dose level to give a total of 48 subjects. Module 2 will include 1 dose level with 12 subjects only.
In this study, subjects will receive multiple doses of ASP9226 or placebo (looks like ASP9226 but has no active ingredients) in the form of tablets which they will swallow with a glass (240 mL) of water.
Subjects will undergo the following during the study: demographic data and medical history will be collected; height and weight will be measured; screening for drugs-of-abuse, alcohol and cotinine; pregnancy testing; vital signs will be taken; physical examinations, electrocardiograms and electroencephalograms will be performed; different kinds of urine and blood safety tests will be performed; blood and urine samples will be taken for measurement of the concentration of ASP9226 and for metabolic profiling; assessments of suicidality will be performed; assessments of abuse liability will be performed including cognitive testing; a blood sample for DNA analysis will be taken and any adverse events that subjects experience and other medications that they take, will be recorded
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0138
Date of REC Opinion
12 Jun 2013
REC opinion
Further Information Favourable Opinion