Healthy
Conditions
Brief summary
This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.
Detailed description
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.
Interventions
DRUGSAGE-217 high dose
high dose
DRUGPlacebo
placebo
DRUGSAGE-217 low dose
low dose
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep efficiency, as determined by polysomnography (PSG) | 16 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed