A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model

A Randomized, Double-Blind, Multiple Dose, 3-way Crossover, Exploratory Study to Assess the Pharmacodynamic Effects of SAGE-217 Capsules in Healthy Adults Using a 5-hour Phase Advance Model of Insomnia

This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.

Subjects are expected to complete Treatment Periods 1, 2 and 3, followed by an optional open-label administration of SAGE-217 for pharmacokinetic purposes (Treatment Period 4).

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Inclusion Criteria:

• Subject is willing and able to participate in the study, including all assessments, planned inpatient stays and all follow-up visits
• Subject is a healthy, ambulatory volunteer
• Subject meets sleep Qualification criteria

Exclusion Criteria:

• Subject has a medical history of suicidal behavior, epilepsy, eating disorders, sleep disorders, or circadian rhythm disorders
• Subject has worked a night shift or flown >1 time zone within 30 days prior to Screening