GTx-758: Phase II data

An open-label Phase II trial in 60 healthy male volunteers showed that 1,000 and 1,500 mg/day oral GTx-758 suppressed serum total testosterone to castrate levels of <50 ng/dL within 3 weeks, while the 600 mg dose did not. All doses of GTx-758 produced increases in serum levels of sex hormone-binding globulin ( SHBG; SBP), a protein that binds to testosterone, and markedly reduced serum free testosterone to levels below those achieved with luteinizing hormone-releasing hormone (LHRH) treatment. GTx-758 was well tolerated with no serious adverse events reported. ...