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

Sponsor

Sage Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT03844906

Collaborator

(none)

Enrollment

Locations

Arms

3.1

Actual Duration (Months)

Patients Per Site

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: SAGE-718 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Dec 27, 2018

Actual Primary Completion Date :

Mar 18, 2019

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAGE-718	Drug: SAGE-718 SAGE-718 in combination with Ketamine
Placebo Comparator: Placebo	Drug: Placebo Placebo in combination with Ketamine

Arm

Intervention/Treatment

Experimental: SAGE-718

Drug: SAGE-718

SAGE-718 in combination with Ketamine

Placebo Comparator: Placebo

Drug: Placebo

Placebo in combination with Ketamine

Outcome Measures

Primary Outcome Measures

Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo [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 [From Day 1 through Day 11]

Secondary Outcome Measures

Number of Participants with the Incidence of Adverse Events and Serious Adverse Events. [Between Baseline and Day 26]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sage Investigational Site	Long Beach	California	United States	90806
2	Sage Investigational Site	Berlin	New Jersey	United States	08009

Sponsors and Collaborators

Sage Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sage Therapeutics

ClinicalTrials.gov Identifier:

NCT03844906

Other Study ID Numbers:

718-EXM-103

First Posted:

Feb 19, 2019

Last Update Posted:

Feb 4, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 4, 2022