Researchers today announced the initiation of a Phase I multiple ascending dose clinical trial evaluating GTx-758. A Phase I single ascending dose clinical trial in 96 subjects was successfully completed in June 2009.

In the completed Phase I single ascending dose clinical trial, GTx-758 was well tolerated. The product demonstrated a pharmacokinetic profile compatible with once daily oral dosing and systemic exposures increasing with dose.

The ongoing Phase I multiple ascending dose clinical trial is an open label, single center study of five dose groups of GTx-758, with ten healthy male subjects per group each receiving doses for 10 days. The study will evaluate the safety, tolerability and pharmacokinetic profile of GTx-758. In addition, testosterone and other hormones will be measured to assess the activity of GTx-758 on hormones secreted by the pituitary, hypothalamus, and adrenal glands.

GTx expects to complete this Phase I multiple ascending dose clinical trial in the fourth quarter.