Farmea

Primary study objective To evaluate the pharmacokinetic characteristics of Daridorexant after oral administration in healthy adult subjects Secondary study objective To evaluate the safety and tolerability of Daridorexant after oral administration in healthy adult subjects

Main study objectives: To evaluate the efficacy of 50 mg Daridorexant on the objective sleep parameter wake time after sleep onset (WASO) (sleep maintenance index) measured by polysomnography (PSG) in patients with insomnia disorder. Secondary study objectives: To evaluate the efficacy of 50 mg Daridorexant on the subjective sleep parameter total sleep time (sTST) (sleep duration index) and the objective sleep parameter sleep latency (LPS) (sleep latency index) measured by PSG in patients with insomnia disorder. Other study objectives: To evaluate the efficacy of 50 mg Daridorexant on the subjective sleep parameters wake time after sleep onset (sWASO) (sleep maintenance index) and subjective sleep latency (sLSO) (sleep latency index) in patients with insomnia disorder and the objective sleep parameter total sleep time (TST) (sleep duration index) measured by PSG. To evaluate the plasma concentration of patients with insomnia disorder after taking the drug. Exploratory objectives: To explore the effect of 50 mg Daridorexant on the health status scale EQ-5D-5L in subjects with insomnia disorder. To evaluate the exposure-response relationship. Safety Objective: To evaluate the safety and tolerability of Daridorexant in subjects with insomnia disorder during and after treatment discontinuation.

Primary Objective: To demonstrate the superiority of Debio 1143 added to CRT compared to placebo in LA-SCCHN. Secondary Objectives: To evaluate the effectiveness of Debio 1143 added to CRT compared to placebo based on additional efficacy endpoints. To evaluate the safety, tolerability, and treatment compliance of Debio 1143 added to CRT compared to placebo. To evaluate the health-related quality of life of Debio 1143 added to CRT compared to placebo using a patient-reported outcomes questionnaire.