A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model
A Randomized, Double-Blind, Multiple Dose, 3-way Crossover, Exploratory Study to Assess the Pharmacodynamic Effects of SAGE-217 Capsules in Healthy Adults Using a 5-hour Phase Advance Model of Insomnia
1 other identifier
interventional
45
1 country
1
Brief Summary
This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2017
CompletedStudy Start
First participant enrolled
September 14, 2017
CompletedFirst Posted
Study publicly available on registry
September 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2017
CompletedNovember 29, 2023
November 1, 2023
3 months
September 13, 2017
November 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Sleep efficiency, as determined by polysomnography (PSG)
16 days
Secondary Outcomes (5)
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
Study Arms (3)
SAGE-217 high dose
EXPERIMENTALSAGE-217
SAGE-217 low dose
EXPERIMENTALSAGE-217
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (1)
Sage Investigational Site
New York, New York, 10019, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2017
First Posted
September 15, 2017
Study Start
September 14, 2017
Primary Completion
December 4, 2017
Study Completion
December 18, 2017
Last Updated
November 29, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/