Overview

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

Status:
Completed
Trial end date:
2018-04-10
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Taisho Pharmaceutical R&D Inc.
Treatments:
Ketamine
Criteria
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