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