6 results
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
Estimate the maximum tolerated dose (MTD) of AEB071 (dose escalation) and characterize the safety and tolerability of the MTD or recommended Phase 2 dose of AEB071 in patients with metastatic uveal melanoma (dose expansion).
The purpose of the study is to investigate the effect on the body of enoxaparin manufactured by the Sponsor (this is called pharmacodynamics) and to compare it with the pharmacodynamic effect of Clexane®. In addition, it will be investigated to what…
Primary objectivesThe primary objective of the study is demonstrate that at least one of the sotrastaurin treatment arms is non-inferior to the active control regimen myfortic + tacrolimus with respect to composite efficacy failure (treated BPAR of…
The primary objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), or vitamin K antagonist (VKA)) in the treatment and secondary prevention of VTE in pediatric subjects…
The primary objectives of this study are to:* Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY 1217389 given in combination with intravenous (IV) paclitaxel using an intermittent…