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

Ketamine

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.

Intervention / Treatment

  • SAGE-718 (DRUG)
    SAGE-718 in combination with Ketamine
  • Placebo (DRUG)
    Placebo in combination with Ketamine

Condition or Disease

  • Healthy Volunteer

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 40 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 27, 2018 ACTUAL
    Primary Completion: Mar 18, 2019 ACTUAL
    Completion Date: Apr 01, 2019 ACTUAL
    Study First Posted: Feb 19, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 20, 2022

    Sponsors / Collaborators

    Lead Sponsor: Sage Therapeutics
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Long Beach, California, USA
    Berlin, New Jersey, USA

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • 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 Outcomes
    • Number of Participants with the Incidence of Adverse Events and Serious Adverse Events. Between Baseline and Day 26

    More Details

    NCT Number: NCT03844906
    Other IDs: 718-EXM-103
    Study URL: https://clinicaltrials.gov/study/NCT03844906
    Last updated: Sep 29, 2023