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

NCT03770780 | Completed Phase 1 FDA Drug

• 1 other identifier: 718-EXM-102
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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 electroencephalograms (EEGs)

  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

• 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

Study Arms (2)

SAGE-718

EXPERIMENTAL

Drug: SAGE-718

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SAGE-718 DRUG

SAGE-718 in combination with Ketamine

SAGE-718

Placebo DRUG

Placebo in combination with Ketamine

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (2)

Sage Investigational Site

Long Beach, California, 90806, United States

Location

Sage Investigational Site

Berlin, New Jersey, 08009, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: December 10, 2018
• Study Start: November 12, 2018
• Primary Completion: March 8, 2019
• Study Completion: March 22, 2019
• Last Updated: September 17, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)