3 results
The primary endpoint is overall survival (OS) in patients with low hENT1 expression. Ifthe hENT1 expression data are available for analysis prior to randomizing 250 patientsthen an interim analysis for sample size re-estimation may be performed.
Primary Objectives:• Evaluate the safety and tolerability of sparsentan oral suspension (Population 1 and Population 2) and tablets (Population 3)• Assess changes in proteinuria after once-daily dosing of sparsentan oral suspension and tablets over…
To determine whether polystyrene sulfonate has an effect on exposure of amitriptyline, when taken simultaneously, compared to amitriptyline taken alone in healthy volunteers, expressed in Cmax and AUC0-8h.