5 results
Primary:to evaluate the safety and tolerability of single dose administration of the study drug in healthy male subjectsto determine the pharmacokinetic parameters following single dose administration of the study drug in healthy male subjectso…
The study will be performed in 3 parts, Parts 1, 2 , 3. and 4 (DDI). The purpose of the study is to investigate how safe the compound is and how well the compound is tolerated; this will be investigated in all study parts. In Parts 1 and 2, it will…
Primary Objective: The primary objective is to evaluate the efficacy of 2 doses ofperampanel (8 and 12 mg) in comparison to placebo given as an adjunctive therapy insubjects with refractory partial seizures.Secondary Objective: The secondary…
Primary Objective* To demonstrate the efficacy of adjunctive perampanel therapy, compared to placebo on primary generalized tonic-clonic (PGTC)seizuresSecondary Objectives* To evaluate the safety and tolerability of perampanel in subjects with…
The study will compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) by assessment of Overall Survival in HPV-unrelated participants. The formal statistical analysis will be performed to test the following…