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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: SAGE-718; Drug: Placebo

• Registration Number: NCT03844906
• Lead Sponsor: Sage Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-19
• Study Start: 2018-12-27
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-19
• Primary Completion: 2019-03-18
• Study Completion: 2019-04-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Subject has a body weight ≥50 kg and body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at screening.
2. Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator.

Exclusion Criteria

1. Subject has any clinically significant abnormal value for hematology, clinical chemistry, or urinalysis at screening or admission.
2. 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.
3. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SAGE-718	SAGE-718	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.	Between Baseline and Day 26

Trial Locations

Locations (1)

Sage Investigational Site; 🇺🇸 Berlin, New Jersey, United States