Phase 2
N=12
Electrophysiological Biomarkers of AV-101
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03583554 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Mean 40-Hz Auditory Steady State Response Power — 0.34; 0.43; 0.60 uV^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); AV-101 720 mg (Drug); AV-101 1440 mg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Marijn Lijffijt, PhD
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean 40-Hz Auditory Steady State Response Power |
0.34; 0.43; 0.60 | — |
| SECONDARY Peak Change in Plasma Concentration of AV-101 Marker 4-Chloro-kynurenine |
0; 28,532; 51,450 | — |
| SECONDARY Peak Change in Plasma Concentration of AV-101 Marker 7-Chloro-kynurenic Acid |
0; 93; 412 | — |
| SECONDARY Mean Systolic Blood Pressure |
122.5; 119.6; 120.1 | — |
| SECONDARY Mean Diastolic Blood Pressure |
80.8; 79; 76.3 | — |
| SECONDARY Mean Pulse |
68.8; 70.5; 69.9 | — |
| SECONDARY Mean Profile of Moods Scale Total Score |
11.6; 12; 11.6 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03583554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.