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

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Single-blind, Parallel-group Study to Evaluate the Effects of TS-134 on Ketamine-induced BOLD Signals in Resting fMRI in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141658
• Other study ID #: TS134-US103
• Status: Completed
• Phase: Phase 1
• Start date: June 28, 2017
• Est. completion date: April 10, 2018

Study information

• Verified date: April 2018
• Source: Taisho Pharmaceutical R&D Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 10, 2018
• Est. primary completion date: April 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TS-134
Multiple dose titrations from 10 mg to 20 mg once daily for 6 days
• TS-134
Multiple dose titrations from 10 mg to 60 mg once daily for 6 days
• Placebo
Multiple doses of placebo once daily for 6 days

Other:
• Ketamine
0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical R&D Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD fMRI signals in pre-specified ROIs	Changes in ketamine-induced BOLD fMRI signals in pre-specified ROIs (anterior cingulate cortex (ACC) and anterior insula) following administrations of TS-134	Screening and Day 6
Secondary	BOLD fMRI signals in whole brain	Changes in ketamine-induced BOLD fMRI signals in whole brain following administrations of TS-134	Screening and Day 6
Secondary	Brief Psychiatric Rating Scale (BPRS)	Changes in BPRS scores following administrations of TS-134	Screening and Day 6
Secondary	Clinician Administered Dissociative State Scale (CADSS)	Changes in CADSS scores following administrations of TS-134	Screening and Day 6