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Completed

NCT Number: NCT03844906

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sage Investigational Site, Long Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SAGE-718

Drug

SAGE-718 in combination with Ketamine

Placebo

Drug

Placebo in combination with Ketamine

Primary outcomes

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

    Time frame: From Day 1 through Day 11

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

    Time frame: From Day 1 through Day 11

Secondary outcomes

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

    Time frame: Between Baseline and Day 26

Sponsors and collaborators

Lead sponsor

Supernus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2019
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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