This study is a phase 1, double-blind, placebo-controlled crossover study of SAGE-718 using a ketamine challenge, to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic response using magnetic resonance imaging in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
19
Sage Investigational Site
Long Beach, California, United States
Sage Investigational Site
Berlin, New Jersey, United States
Change in glutamate and glutamine (GLX) in the anterior cingulate cortex (ACC), hippocampus, and pons as measured with magnetic resonance spectroscopy (MRS)
Time frame: Between Day 1 and Day 11
Change in glutamate in the ACC, hippocampus, and pons, as measured with MRS
Time frame: Between Day 1 and Day 11
Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by incidence of adverse events (AEs)/serious AEs (SAEs)
Time frame: Between Baseline and Day 27
Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by electroencephalograms (EEGs)
Observed values and change from baseline in EEGs in patients post study drug administration
Time frame: Between Baseline and Day 27
Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by electrocardiograms (ECGs)
Observed values and change from baseline in ECGs in patients post study drug administration
Time frame: Between Baseline and Day 27
Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Between Baseline and Day 27
Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Brief Psychiatric Rating Scale (BPRS)
Time frame: Between Baseline and Day 27
Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Clinician Administered Dissociative State Scale (CADSS)
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Time frame: Between Baseline and Day 27
Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Observer's Assessment of Alertness and Sedation (OAAS)
Time frame: Between Baseline and Day 27