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NCT03844906 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy Volunteer, sponsored by Supernus Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target
2
Study locations

NCT03844906 is a Phase 1 study of Healthy Volunteer that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 40 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (80% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03844906, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Supernus Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target
2
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG SAGE-718

Study Locations (2)

California

  • Sage Investigational Site - Long Beach

New Jersey

  • Sage Investigational Site - Berlin

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2018-12-27
Est. Completion 2019-04-01
Phase Phase 1

Sponsor

Supernus Pharmaceuticals

57 total trials

What the Registry Record Tells You About NCT03844906

The ClinicalTrials.gov registry entry for NCT03844906 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (80% lower). The listed sponsor is Supernus Pharmaceuticals, which has 57 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03844906 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, New Jersey.

Frequently Asked Questions

What is clinical trial NCT03844906 about?

NCT03844906 is a clinical study titled "A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects". 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.

What is the current status of trial NCT03844906?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-12-27. Estimated completion is 2019-04-01.

What conditions does trial NCT03844906 study?

This clinical trial studies the following conditions: Healthy Volunteer.

What interventions are being tested in trial NCT03844906?

The interventions under investigation include: Placebo (DRUG), SAGE-718 (DRUG).

Who is sponsoring clinical trial NCT03844906?

This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03844906 being conducted?

This trial has 2 study locations across California, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.