Status:
COMPLETED
A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model
Lead Sponsor:
Biogen
Conditions:
Healthy
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
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 previou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2017
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03284931
Start Date
September 14 2017
End Date
December 18 2017
Last Update
November 29 2023
Active Locations (1)
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1
Sage Investigational Site
New York, New York, United States, 10019