(duplicate) Side effects, blood levels & effects of TAK-385 (v4)

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose, Inpatient and Outpatient Study in Healthy Men to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy for Testosterone Lowering of TAK-385, an Oral Gonadotropin-Releasing Hormone (GnRH) Antagonist

• IRAS ID

  106949

• Contact name

  Steve Warrington

• Sponsor organisation

  Millennium Pharmaceuticals, Inc

• Eudract number

  2011-002868-24

• ISRCTN Number

  n/a

• Research summary

  The study medicine (TAK-385) is an experimental treatment for prostate cancer: the most common type of cancer in men in Europe and the USA. We hope that TAK-385 will be more effective than existing treatments, and have fewer side effects.We??re doing this 3-part study in healthy men. We'll give TAK-385 by mouth (as tablets) in each part.* Part 1: single doses in 32 men aged 18??50 years* Part 2: 14 daily doses in up to 56 healthy men aged 40??70 years* Part 3: 28 daily doses in up to 66 healthy men aged 50??75 yearsWe'll investigate TAK-385??s side effects, blood levels and effects on hormones (such as testosterone), and find out whether food affects its absorption into the bloodstream.Men in Part 1 will take up to 8 weeks to finish the study, make 2 outpatient visits, and have 1 or 2 inpatient stays (up to 8 nights in total). Men in Part 2 will take up to 8 weeks to finish the study; make 2 outpatient visits; and have 1 inpatient stay (17 nights in total). Men in Part 3 will take up to 12 weeks to finish the study; make 5 outpatient visits; and have 2 inpatient stays (4 nights in total). Men in Parts 1 and 2 will take every dose of TAK-385 in the research unit. Men in Part 3 will take 6 doses in the unit, and 22 doses at home. A pharmaceutical company (Millennium Pharmaceuticals Inc) is funding the study.The study will take place at 1 centre in London. We'll recruit healthy men by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0109

• Date of REC Opinion

  5 Sep 2011

• REC opinion

  Further Information Favourable Opinion