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CompletedNCT03844906Updated Sep 17, 2025

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

A Phase 1 interventional study of SAGE-718 and Placebo in Healthy Volunteer, sponsored by Supernus Pharmaceuticals, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by Supernus Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Mar 2019, 7 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Supernus Pharmaceuticals, Inc. is the lead sponsor of 61 studies on the registry; 6 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 25 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Subject has a body weight ≥50 kg and body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at screening.
  2. Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator.

Exclusion criteria

Exclusion Criteria:

  1. Subject has any clinically significant abnormal value for hematology, clinical chemistry, or urinalysis at screening or admission.
  2. 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.
  3. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    SAGE-718

    Drug: SAGE-718

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugSAGE-718

    SAGE-718 in combination with Ketamine

  • DrugPlacebo

    Placebo in combination with Ketamine

06

What researchers measure

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

07

Study locations

2 sites
  • Sage Investigational Site
    Long Beach, California 90806, United States
  • Sage Investigational Site
    Berlin, New Jersey 08009, United States
08

References and documents

Individual participant data

Plan to share: No — Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03844906
Lead sponsor
Supernus Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Feb 19, 2019
Start date
Dec 27, 2018
Primary completion
Mar 18, 2019
Completion
Apr 1, 2019
Last update
Sep 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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