MedTrace Logo

Electrophysiological Biomarkers of AV-101

NCT03583554 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-02-17

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy

Interventions

DRUG

Placebo

Single dose of 4 placebo oral capsules

DRUG

AV-101 720 mg

Single dose of 2 360 mg AV-101 oral capsules + 2 placebo oral capsules

DRUG

AV-101 1440 mg

Single dose of 4 360 mg AV-101 oral capsules

Sponsors & Collaborators

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • VistaGen Therapeutics, Inc.

    collaborator INDUSTRY

  • Marijn Lijffijt, PhD

    lead OTHER

Principal Investigators

  • Marijn Lijffijt, PhD · Baylor College of Medicine and the Michael E. DeBakey VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-10-19
Completion
2019-10-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03583554 on ClinicalTrials.gov