Astellas - Single dose ASP1707 in healthy young Japanese male subjects

• Research type

  Research Study

• Full title

  A double blind, randomized and placebo controlled ascending single oral dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of ASP1707 in healthy young Japanese male subjects.

• IRAS ID

  76488

• Contact name

  Muna Albayaty

• Sponsor organisation

  Astellas Pharma Europe B.V. (APEB)

• Eudract number

  2010-024040-15

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The study drug does not yet have a name and is only known by the code ASP1707. It is predicted that the study drug will be useful as a treatment for prostate cancer in males. The prostate is a small gland in the pelvis that is 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. If the amount of testosterone in the body is lowered, it is possible to slow down or shrink the prostate cancer. The study drug (ASP1707) will be used as hormone therapy to lower testosterone levels and thereby control the growth and spread of the prostate cancer. It is expected that the study drug will block the production of luteinizing hormone (LH) and lower the levels of follicle stimulating hormone (FSH) and testosterone. LH and FSH play an essential role in testosterone production. Testosterone is a male hormone required for sperm production, the development of male reproductive organs and the emergence of secondary male sexual characteristics such as facial hair, a deeper voice and muscles. This study will be performed in young Japanese male participants using a single increasing dose procedure under fasting conditions, to find out what changes occur in these hormone levels and also how much of ASP1707 gets into the blood stream. Healthy volunteers can not benefit from this study. A pharmaceutical company, Astellas Pharma Europe B.V. (APEB) is sponsoring this study. This study will take place at one study centre in the United Kingdom.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0025

• Date of REC Opinion

  12 Apr 2011

• REC opinion

  Further Information Favourable Opinion