Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants

ClinicalTrials.gov ID: NCT05049343

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Official title

A Phase 1, Double-Blind, Placebo-Controlled Crossover Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary purpose of this study is to determine functional target engagement of SAGE-904 using electrophysiological paradigms before and after ketamine administration.

Study identification

NCT ID: NCT05049343
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Supernus Pharmaceuticals, Inc.; Industry
Enrollment: 22 participants

Conditions and interventions

Conditions

Healthy Volunteer

Interventions

SAGE-904 Drug
Placebo Drug
Ketamine Drug

Drug

Eligibility (public fields only)

Age range: 21 Years to 55 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 21, 2021 (Actual)
Primary completion: Nov 20, 2021 (Actual)
Completion: Dec 3, 2021 (Actual)
Last update posted: Sep 17, 2025

2021

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Sage Investigational Site	Newark	New Jersey	07103	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05049343, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 17, 2025 · Synced Nov 15, 2026