6 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…
To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)
Primary objectives: -To evaluate the PK profile of OBE001 when administered orally to pregnant women.Secondary objectives: -To evaluate the maternal safety and tolerability of OBE001 when administered orally to pregnant women.-To evaluate the acute…
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 objective:To assess the bioequivalence of SOF/VEL as a crushed (test) tablet compared to a whole (reference) tablet in patients treated with SOF/VELSecondary objective:To evaluate the safety and tolerability of crushed SOF/VEL tablets in…
Primary objective:To assess the bioequivalence of single-dose velpatasvir administered as a fixed-dose combination of sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) when given with cola + omeprazole 40mg (test 1/trt A) compared to velpatasvir…