Electrophysiological Biomarkers of AV-101

• Status: Completed
• Trial end date: 2019-10-19
• Target enrollment: 0
• Participant gender: All

Summary

Suicide is 2-7x higher in Veterans than non-veterans, and may be related to brain kynurenine pathway (KP) dysregulation and NMDA receptor (NMDAR) hyperactivation. Experimental drug "AV-101" modulates the brain KP, with possible downstream NMDAR deactivation. The investigators will examine AV-101 NMDAR modulation by testing dose-response effects on resting state EEG, Mismatch Negativity, and P50 gating. Twelve healthy Operation Enduring Freedom (OEF) Operation Iraqi Freedom (OIF) and Operation New Dawn (OND) Veterans will be administered single dose AV-101 720 mg, 1440 mg, and placebo over 3 weeks in a randomized, double-blind, cross-over trial. Repeated measures General Linear Models will test dose-response effects. Suicide prevention is an important Veterans Affair (VA) mission. This study is a first step to testing anti-suicidal effects of AV-101 in Veterans.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Marijn Lijffijt, PhD
• Collaborators: Michael Debakey Veterans Affairs Medical Center; Michael E. DeBakey VA Medical Center; VistaGen Therapeutics, Inc.

Criteria

Inclusion Criteria

• Age 21-64, inclusive

• US military Veteran

• Healthy volunteer.

• Subject and partner are both using at least 1 medically accepted contraception (double barrier) at randomization until 1 month after single dose

Exclusion Criteria

• History of any Axis 1 psychiatric condition

• History of psychosis in first-degree family members

• History of use of psychoactive medication

• Current use of any medication or vitamins except the pill (women)

• History of use of any substances of abuse, except for alcohol, caffeine, and nicotine

• Positive at tests for alcohol and illicit substance at screening and study visits.

• History of epilepsy, head injury, stroke, primary neurological disorder

• Clinically significant abnormal laboratory values, vital signs or ECG placing participants at risk for serious adverse events as determined by the study physician

• Pregnant or nursing

• Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease