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Clinical Trials/NCT03844906
NCT03844906CompletedPhase 1

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

Supernus Pharmaceuticals, Inc.1 site in 1 country40 target enrollmentStarted: December 27, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

SAGE-718

Experimental

Intervention: SAGE-718 (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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

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

  • Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.(Between Baseline and Day 26)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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