A Phase 1 interventional study of SAGE-217 high dose and Placebo in Healthy, sponsored by Biogen. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by Biogen · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
SAGE-217
Drug: SAGE-217 high dose
SAGE-217
Drug: SAGE-217 low dose
Placebo
Drug: Placebo
high dose
placebo
low dose
Sleep efficiency, as determined by polysomnography (PSG)
Time frame: 16 days
Safety and tolerability, as assessed by adverse events
Time frame: 36 days
Safety and tolerability, as assessed by vital signs
Time frame: 29 days
Safety and tolerability, as assessed by clinical laboratory data
Time frame: 29 days
Safety and tolerability, as assessed by ECG
Time frame: 29 days
Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 29 days
Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sleep Initiation and Maintenance Disorders→
Biogen