Absorption-Metabolism-Excretion study of (14C)labelled ASP1707

• Research type

  Research Study

• Full title

  An open label study to evaluate the pharmacokinetics of ASP1707 after a single oral dose of (14C)labelled ASP1707 in healthy male subjects.

• IRAS ID

  82771

• Contact name

  Ashley Brooks

• Sponsor organisation

  Astellas Pharma Europe B.V. (APEB)

• Eudract number

  2011-001701-27

• Research summary

  The study drug is known as ASP1707. It is predicted to be useful in treating prostate cancer. The prostate is a small gland in the pelvis, found only in men. It is located between the penis and the bladder and surrounds the urethra, the tube that carries urine from the bladder to the penis. Prostate cancer depends on the male hormone testosterone for its growth. Testosterone is required for sperm production, development of male reproductive organs and emergence of secondary male sexual characteristics such as facial hair, deeper voice and muscles. If its amount in the body's lowered, it is possible to slow down or shrink the prostate cancer. ASP1707 will be used as hormone therapy to lower testosterone levels and control the growth and spread of prostate cancer. In this study 6 male subjects will receive single oral doses of ASP1707, to which a radioactive substance (14C) will be chemically attached. Radioactivity Levels measurements in blood, urine and faeces will help determine how the drug is excreted by the body.Subjects will remain resident in the unit for 7 days after dosing and be discharged thereafter provided certain criteria regarding for radioactivity are met. If the criteria are not met, the residential period will be extended with an additional 3 days maximum. Excretion will be measured daily and subjects will be discharged when they meet the criteria. If the criteria are not met after 10 days, subjects will be discharged and asked to provide urine and faecal collections as outpatients for radioactivity measurements.The study period from screening to the last outpatient will last less than 7 weeks. Healthy volunteers can not 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 West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0119

• Date of REC Opinion

  21 Jul 2011

• REC opinion

  Favourable Opinion