NCT03771586

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

A Phase 1, Double-blind, Placebo-controlled Crossover Study of SAGE-718 Using a Ketamine Challenge, to Evaluate the Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a phase 1, double-blind, placebo-controlled crossover study of single, oral dose of SAGE-718 using a 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: 2018-09-24
• Primary completion: 2018-12-17
• Completion: 2019-01-02
• First posted: 2018-12-11
• Last updated: 2025-09-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study