5 results
Primary:-To assess the mass balance profile (ie, excretion in urine and feces) of orteronel after a single oral dose of 400 mg orteronel containing 18.5 kBq (500 nCi) of 14[C]-orteronel-To characterize the pharmacokinetic profile of total…
Primary Objective:• To determine if orteronel plus prednisone improves overall survival (OS)Key Secondary Objectives: • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)• To determine if orteronel plus…
Primary objective:* To determine whether orteronel 300 mg twice daily (BID) plus prednisone 5 mg BID more effectively reduces serum testosterone levels, compared to placebo plus prednisone 5 mg BID, when administered to patients in JapanSecondary…
Our hypothesis is that continuous intravenous glucose monitoring is helpful in ICU patients treated with IIT to:a) reach and maintain the glucose-target of 4.4-6.1 mmol/L soonerb) to increase safety, by eliminating the development of hypoglycaemiac…
To compare the effect of oxygenated versus non-oxygenated hypothermic machine perfusion of grafts of DCD category III (awaiting circulatory death - controlled), kidneys aged 50 years or older on kidney graft function.