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

Biogen45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

SAGE-217 high doseDRUG

high dose

PlaceboDRUG

placebo

SAGE-217 low doseDRUG

low dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sage Investigational Site

New York, New York, United States

Outcomes

Primary Outcomes

Sleep efficiency, as determined by polysomnography (PSG)

Time frame: 16 days

Secondary Outcomes

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

Data from ClinicalTrials.gov

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