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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 64
Updated:1/21/2018
Start Date:September 14, 2017
End Date:December 18, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

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

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).

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
We found this trial at
1
site
Sage Investigational Site
New York, New York 10029
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mi
from
New York, NY
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