Effects of TS-134 on Ketamine-induced BOLD Signals in Healthy Subjects

Ketamine

Brief Summary

The purpose of this study is to evaluate the effects of TS-134 on ketamine-induced BOLD signals in ROIs in resting fMRI in healthy adult subjects.

Intervention / Treatment

  • TS-134 (DRUG)
    Multiple dose titrations from 10 mg to 60 mg once daily for 6 days
  • Placebo (DRUG)
    Multiple doses of placebo once daily for 6 days
  • Ketamine (OTHER)
    0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6

Condition or Disease

  • Healthy Volunteers

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 55 Years
    Enrollment: 63 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jun 28, 2017 ACTUAL
    Primary Completion: Apr 04, 2018 ACTUAL
    Completion Date: Apr 10, 2018 ACTUAL
    Study First Posted: May 05, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 27, 2018

    Sponsors / Collaborators

    Lead Sponsor: Taisho Pharmaceutical R&D Inc.
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    New York, New York, USA

    Participant Groups

    • No description provided

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 55
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Healthy adult male and female subjects between 18 and 55 years of age inclusive (at the time of initial informed consent)
    * Body weight ≥ 45 and ≤ 87 kg
    * Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2

    Exclusion Criteria:

    * Female subjects who are pregnant, intend to become pregnant, or are breastfeeding
    * History or presence of psychiatric or neurologic disease or condition
    * History of first-degree relative with schizophrenia or mood disorder with psychosis
    * History of alcohol or drug abuse
    * History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine
    * History of violence
    * Presence or positive history of significant medical illness, including high blood pressure, low blood pressure or orthostatic hypotension
    * Any subjects who show subthreshold ketamine BOLD response
    * Metal implants, pacemaker, other metal or paramagnetic objects contained within the body
    * Claustrophobia
    * Subject with any history of suicidal behavior or is currently at risk of suicide in the opinion of the investigator

    Primary Outcomes

    • Changes in ketamine-induced BOLD fMRI signals in pre-specified ROIs (anterior cingulate cortex (ACC) and anterior insula) following administrations of TS-134

    Secondary Outcomes

    • Changes in ketamine-induced BOLD fMRI signals in whole brain following administrations of TS-134

    • Changes in BPRS scores following administrations of TS-134

    • Changes in CADSS scores following administrations of TS-134

    More Details

    NCT Number: NCT03141658
    Other IDs: TS134-US103
    Study URL: https://clinicaltrials.gov/study/NCT03141658
    Last updated: Sep 29, 2023