A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects

NCT03771586 | Completed Phase 1 FDA Drug

• 1 other identifier: 718-EXM-101
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a phase 1, double-blind, placebo-controlled crossover study of single, oral dose of SAGE-718 using a ketamine challenge, to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy subjects

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Change in the electrophysiological parameters, auditory evoked potentials, between pre- and post-ketamine infusion in subjects receiving SAGE-718 vs the change in parameters between pre- and post-ketamine infusion in subjects receiving placebo

  Between Day 1 and Day 11

Secondary Outcomes (7)

• Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by the 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 changes from baseline in 12-lead electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities

  Between Baseline and Day 12

• Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in electroencephalograms (EEGs) including Delta, Theta, Alpha, Beta.

  Between Baseline and Day 12

• Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS).

  Between Baseline and 27 days

• Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in Brief Psychiatric Rating Scale (BPRS).

  Between Day 1 and Day 11

Study Arms (2)

SAGE-718

EXPERIMENTAL

Drug: SAGE-718

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SAGE-718 DRUG

SAGE-718 in combination with Ketamine

Also known as: 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 has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening.
• If female, subject is post-menopausal (at least 12 months of spontaneous amenorrhea with confirmatory follicle stimulating hormone \>40 mIU/mL), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, and/or hysterectomy).
• 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 obstructed venous access and/or has skin disease, rash, acne, or abrasion at venous access site that may affect the ability to obtain a PK sample or affect the ability to receive the ketamine infusions.
• Subject has had previous exposure to or is known to be allergic to ketamine or any of its excipients.

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

Related Links

• Related Info

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

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: October 2, 2018
• First Posted: December 11, 2018
• Study Start: September 24, 2018
• Primary Completion: December 17, 2018
• Study Completion: January 2, 2019
• Last Updated: September 17, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)