5 results
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:-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 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…
Primary objectiveThe primary objective of this study is to assess the efficacy of gabapentin relative to tramadol for the treatment of moderate to severe chronic neuropathic or mixed pain in children from 3 months to less than 18 years of age.…
We will investigate how safe the study device DV3395-C1 is when it is taken in by healthy participants. We will also look at the passage (i.e., gastrointestinal transit time) and activation of the study device. For this, we will see if the device…