Effect of Higher Exposure of an IMP on Testosterone Levels

• Research type

  Research Study

• Full title

  Open label study of the effect of higher exposure of GTx-758 on testosterone and free testosterone levels in men

• IRAS ID

  67773

• Contact name

  Stephen Smith

• Sponsor organisation

  Celerion on behalf of GTx, Inc.

• Eudract number

  2010-023572-13

• Research summary

  This study will explore the effect of a higher dose of an Investigational Medicinal Product (IMP) on the levels of testosterone in healthy older men than has been given in previous studies. The purpose of this study is to:- Find out the percentage of volunteers whose testosterone levels fall below a certain value after a 2000 mg dose of the IMP is given.- Look at the safety of and the ability of the body to tolerate a single dose and multiple doses (up to 21 days in a row) of the IMP.- Look at the extent to which single and multiple doses of the IMP are absorbed into the blood stream. Older male volunteers will take part in this study at one centre in the UK. The duration of the study from screening until the final visit could be up to 53 days. Volunteers will receive up to 22 doses during the study (a single dose on Day 1 with multiple dosing commencing on Day 4 through to Day 24).

• REC name

  HSC REC A

• REC reference

  10/NIR01/63

• Date of REC Opinion

  1 Dec 2010

• REC opinion

  Further Information Favourable Opinion