Adults 18 to 64, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean 40-Hz Auditory Steady State Response PowerPrimary· 4 hours
Mean power (in microVolt squared; uV\^2) of 40-Hz Auditory Steady State Response (ASSR; an auditory task using 40Hz click trains) calculated across 38-42Hz.
Mean +/- SE across pre-treatment baseline and 4 post-treatment measures one every hour controlled for time, with outcomes the mean per treatment arm obtained from Linear Mixed Model analysis.
Group
Value
95% CI
Placebo
0.34
± 0.11
AV-101 720 mg
0.43
± 0.11
AV-101 1440 mg
0.60
± 0.11
Peak Change in Plasma Concentration of AV-101 Marker 4-Chloro-kynurenineSecondary· 4 hours
Assesses the peak change from baseline and corrected for placebo (placebo set at 0) across a 4 hours time frame after drug intake. 4-Chloro-kynurenine is the main ingredient of AV-101 and is a precursor of 7-Chloro-kynurenic acid.
Group
Value
95% CI
Placebo
0
± 0
AV-101 720 mg
28,532
± 21,462
AV-101 1440 mg
51,450
± 21,182
Peak Change in Plasma Concentration of AV-101 Marker 7-Chloro-kynurenic AcidSecondary· 4 hours
Assesses the peak change from baseline and corrected for placebo (placebo set at 0) across a 4 hours time frame after drug intake. 7-Chloro-kynurenic acid is the main metabolite of AV-101 (4-Chloro-kynurenine).
Group
Value
95% CI
Placebo
0
± 0
AV-101 720 mg
93
± 48
AV-101 1440 mg
412
± 473
Mean Systolic Blood PressureSecondary· 5 hours
Systolic blood pressure Mean +/- SE averaged across all timepoints (including baseline). Systolic blood pressure was measured 15 minutes before drug intake and every 15 minutes from drug intake until 5 hours after intake controlled for time, with outcomes the mean per treatment arm obtained from Linear Mixed Model analysis.
Group
Value
95% CI
Placebo
122.5
± 2.7
AV-101 720 mg
119.6
± 2.7
AV-101 1440 mg
120.1
± 2.7
Mean Diastolic Blood PressureSecondary· 5 hours
Diastolic blood pressure Mean +/- SE averaged across all timepoints (including baseline). Diastolic blood pressure was measured 15 minutes before drug intake and every 15 minutes from drug intake until 5 hours after intake controlled for time, with outcomes the mean per treatment arm obtained from Linear Mixed Model analysis
Group
Value
95% CI
Placebo
80.8
± 2.35
AV-101 720 mg
79
± 2.35
AV-101 1440 mg
76.3
± 2.35
Mean PulseSecondary· 5 hours
Pulse Mean +/- SE averaged across all timepoints (including baseline). Pulse was measured 15 minutes before drug intake and every 15 minutes from drug intake until 5 hours after intake controlled for time, with outcomes the mean per treatment arm obtained from Linear Mixed Model analysis
Group
Value
95% CI
Placebo
68.8
± 1.82
AV-101 720 mg
70.5
± 1.82
AV-101 1440 mg
69.9
± 1.82
Mean Profile of Moods Scale Total ScoreSecondary· 5 hours
POMS total score Mean +/- SE averaged across all timepoints (including baseline). Systolic blood pressure was measured directly before drug intake and every hours from drug intake until 5 hours after intake controlled for time, with outcomes the mean per treatment arm obtained from Linear Mixed Model analysis
The POMS is a 40 item scale. Each item is scored on a 0 (absent) - 4 (extreme) scale. POMS total score ranges from 0 to 160. Higher scores mean more extreme dysregulated mood. Subscales are tension (6 items; score anger 0-24), depression (6 items, range 0-24), fatigue (5 items, range 0-2
Group
Value
95% CI
Placebo
11.6
± 1.65
AV-101 720 mg
12
± 1.65
AV-101 1440 mg
11.6
± 1.65
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 hours.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Marijn Lijffijt, PhD
Last refreshed: 17 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03583554.