Absorption,Metabolism,Excretion study of (14C)labelled ASP3652
Research type
Research Study
Full title
An open label study to evaluate the pharmacokinetics of ASP3652 after a single oral dose of 14C-labeled ASP3652 in healthy caucasian male subjects
IRAS ID
106324
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Astellas Pharma Europe B.V (APEB)
Eudract number
2011-004526-10
ISRCTN Number
N/A
Research summary
The study drug is known as ASP3652. It is predicted to be useful as a treatment for chronic pelvic pain in the future. In this study 6 Caucasian male subjects will receive single oral doses of 150 mg of ASP3652, to which radioactive substance (Carbon 14) is chemically attached. Radioactivity level measurements in blood, urine and faeces will help determine how the drug is broken down and excreted from the body. Subjects will remain resident in the Clinical Research Unit for 6 days after dosing and be discharged thereafter provided certain criteria regarding excretion of radioactivity are met. If the criteria are not met, the residential period will be extended with an additional 3 days maximum. Radioactive excretion will be measured daily and subjects will be discharged when they meet the criteria. If the criteria are not met after 9 days, subjects will be discharged and asked to provide daily urine and faecal collections (in the containers provided) as outpatients for radioactivity measurements for the next 3 days. If after these additional 3 days the criteria for radioactivity excretion has not been met the subjects will be requested to collect 24 hour urine and faecal samples once a week for up to 2 weeks. After this time, even if the requisite conditions are not met the subjects will be discharged from the study. An End of Study Visit will take place 7-14 days after (early) discharge and will take place after the required levels of radioactivity have been reached. The study period from screening to the End of Study Visit will last approximately 7-8 weeks (no more than 9 weeks). Healthy volunteers cannot benefit from this study. Astellas Pharma Europe B.V. (APEBV) is sponsoring this study, which will take place at one study centre in the United Kingdom.
REC name
North East - York Research Ethics Committee
REC reference
12/NE/0223
Date of REC Opinion
25 Jun 2012
REC opinion
Further Information Favourable Opinion