5 results
The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC. The…
This study will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GDC-0134 in patients with amyotrophic lateral sclerosis (ALS). Safety Objective: To evaluate the safety of single and multiple…
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…
- To assess the pharmacokinetic profile of cysteamine base after single dose administration of the new sustained-release cysteamine bitartrate (PO-001) to healthy volunteers, in comparison with Cystagon® and Procysbi®.- To collect safety/…
This study will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GDC-0134 in patients with amyotrophic lateral sclerosis (ALS).The long term safety and tolerability of up to 48 weeks of GDC-0134 will…