A Study to Assess the Electrophysiology, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response Using Magnetic Resonance Imaging of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
- Registration Number
- NCT03770780
- Lead Sponsor
- Sage Therapeutics
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- Subject is willing and able to provide 2 forms of identification; at least 1 must have a photo.
- Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening.
- Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator.
Exclusion Criteria
- Subject has a history or presence of any psychiatric disease or condition including suicidal ideation or behavior, has answered YES to any question on the C-SSRS at screening or admission, or is currently at risk of suicide in the opinion of the Investigator
- Subject has a history or presence of a neurologic disease or condition, including but not limited to epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure.
- Subject has a family history of epilepsy.
- Subject has evidence of any metal in the body that may be contraindicated for receiving an MRI. This includes, but is not limited to: cardiac pacemaker, surgical implants, previous accident resulting in metal or shrapnel lodged internally, tattoos inked with metallic dyes, or a history of metal work without using protective eyewear.
- Subject has claustrophobia or a history of claustrophobia.
- Subject is unable or unwilling to remove piercings and/or jewelry that contain metal.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo - SAGE-718 SAGE-718 -
- Primary Outcome Measures
Name Time Method Change in glutamate and glutamine (GLX) in the anterior cingulate cortex (ACC), hippocampus, and pons as measured with magnetic resonance spectroscopy (MRS) Between Day 1 and Day 11
- Secondary Outcome Measures
Name Time Method Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Clinician Administered Dissociative State Scale (CADSS) 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) Between Baseline and Day 27 Change in glutamate in the ACC, hippocampus, and pons, as measured with MRS 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) Between Baseline and Day 27 Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by electrocardiograms (ECGs) Between Baseline and Day 27 Observed values and change from baseline in ECGs in patients post study drug administration
Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Between Baseline and Day 27 Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by electroencephalograms (EEGs) Between Baseline and Day 27 Observed values and change from baseline in EEGs in patients post study drug administration
Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Brief Psychiatric Rating Scale (BPRS) Between Baseline and Day 27
Trial Locations
- Locations (1)
Sage Investigational Site
🇺🇸Berlin, New Jersey, United States