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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: SAGE-217 high dose; Drug: SAGE-217 low dose; Drug: Placebo

• Registration Number: NCT03284931
• Lead Sponsor: Biogen

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.

Study Timeline

• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-13
• Study Start: 2017-09-14
• Study First Posted: 2017-09-15
• Primary Completion: 2017-12-04
• Study Completion: 2017-12-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SAGE-217 high dose	SAGE-217 high dose	SAGE-217
SAGE-217 low dose	SAGE-217 low dose	SAGE-217
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Sleep efficiency, as determined by polysomnography (PSG)	16 days

Secondary Outcome Measures

Name	Time	Method
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 adverse events	36 days
Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)	29 days

Trial Locations

Locations (1)

Sage Investigational Site; 🇺🇸 New York, New York, United States