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

NCT03844906 | Completed Phase 1 FDA Drug

• 1 other identifier: 718-EXM-103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a Phase 1, randomized, double-blind, placebo-controlled study of multiple doses of SAGE-718 using ketamine challenge to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy subjects.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo

  From Day 1 through Day 11

• Number of Participants With Changes in Auditory-Evoked Potentials Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo

  From Day 1 through Day 11

Secondary Outcomes (1)

• Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.

  Between Baseline and Day 26

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 has a body weight ≥50 kg and body mass index (BMI) ≥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 any clinically significant abnormal value for hematology, clinical chemistry, or urinalysis at screening or admission.
• 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 positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.

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: December 19, 2018
• First Posted: February 19, 2019
• Study Start: December 27, 2018
• Primary Completion: March 18, 2019
• Study Completion: April 1, 2019
• Last Updated: September 17, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)