Back to resultsA Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAGE-217 high dose
Placebo
SAGE-217 low dose
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
Eligibility Criteria
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
Sites / Locations
- Sage Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SAGE-217 high dose
SAGE-217 low dose
Placebo
Arm Description
SAGE-217
SAGE-217
Placebo
Outcomes
Primary Outcome Measures
Sleep efficiency, as determined by polysomnography (PSG)
Secondary Outcome Measures
Safety and tolerability, as assessed by adverse events
Safety and tolerability, as assessed by vital signs
Safety and tolerability, as assessed by clinical laboratory data
Safety and tolerability, as assessed by ECG
Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03284931
Brief Title
A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
December 4, 2017 (Actual)
Study Completion Date
December 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sage Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAGE-217 high dose
Arm Type
Experimental
Arm Description
SAGE-217
Arm Title
SAGE-217 low dose
Arm Type
Experimental
Arm Description
SAGE-217
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
SAGE-217 high dose
Intervention Description
high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
SAGE-217 low dose
Intervention Description
low dose
Primary Outcome Measure Information:
Title
Sleep efficiency, as determined by polysomnography (PSG)
Time Frame
16 days
Secondary Outcome Measure Information:
Title
Safety and tolerability, as assessed by adverse events
Time Frame
36 days
Title
Safety and tolerability, as assessed by vital signs
Time Frame
29 days
Title
Safety and tolerability, as assessed by clinical laboratory data
Time Frame
29 days
Title
Safety and tolerability, as assessed by ECG
Time Frame
29 days
Title
Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame
29 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Doherty, PhD
Organizational Affiliation
Sage Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Sage Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model
We'll reach out to this number within 24 hrs