NCT03844906

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	SAGE-718	SAGE-718 in combination with Ketamine
DRUG	Placebo	Placebo in combination with Ketamine

Timeline

• Start date: 2018-12-27
• Primary completion: 2019-03-18
• Completion: 2019-04-01
• First posted: 2019-02-19
• Last updated: 2025-09-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study