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

Ketamine

Brief 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

Intervention / Treatment

Drug: SAGE-718
Drug: Placebo

Condition or Disease

Healthy Volunteer

Phase

Study Design

Study type:	Interventional
Status:	Completed
Study results:	No Results Available
Age:	18 Years to 65 Years (Adult, Older Adult)
Enrollment:	22 ()
Funded by:	Industry
Masking

Clinical Trial Dates

Start date:	Sep 24, 2018
Primary Completion:	Dec 17, 2018
Completion Date:	Jan 02, 2019
Study First Posted:	Dec 11, 2018
Results First Posted:	Aug 31, 2020
Last Updated:	Feb 11, 2019

Sponsors / Collaborators

Lead Sponsor: N/A

Responsible Party: N/A

Location

Long Beach, California, USA

Berlin, New Jersey, USA

Eligibility Criteria

Sex:	All
Minimum Age:	18
Maximum Age:	65

More Details

NCT Number:	NCT03771586
Other IDs:	718-EXM-101
Study URL:	https://ClinicalTrials.gov/show/NCT03771586

Last updated: Jun 17, 2022