A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults 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.

• SAGE-217 high dose (Drug): high dose
• Placebo (Drug): placebo
• SAGE-217 low dose (Drug): low dose

Primary outcomes

• Sleep efficiency, as determined by polysomnography (PSG) [16 days]

Secondary outcomes

• Safety and tolerability, as assessed by adverse events [36 days]
• Safety and tolerability, as assessed by vital signs [29 days]
• Safety and tolerability, as assessed by clinical laboratory data [29 days]
• Safety and tolerability, as assessed by ECG [29 days]
• Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS) [29 days]

Sex: All, ages: 18 Years to 64 Years, accepts healthy volunteers

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