CLINICAL TRIALS PROFILE FOR AV-101
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Clinical Trials for AV-101
Trial ID | Title | Status | Sponsor | Phase | Summary |
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NCT01483846 ↗ | Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers | Completed | Cato Research | Phase 1 | This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on capsaicin-induced hyperalgesia will be assessed. |
NCT01483846 ↗ | Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers | Completed | National Institute on Drug Abuse (NIDA) | Phase 1 | This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on capsaicin-induced hyperalgesia will be assessed. |
NCT01483846 ↗ | Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers | Completed | VistaGen Therapeutics, Inc. | Phase 1 | This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on capsaicin-induced hyperalgesia will be assessed. |
NCT02484456 ↗ | Antidepressant Effects of the Glycine Receptor Antagonist AV-101 (4-chlorokynurenine) in Major Depressive Disorder | Completed | National Institute of Mental Health (NIMH) | Phase 2 | Background: - Drugs and talk therapy help treat depression, but these treatments usually take quite a bit of time to work. Ketamine is a fast-acting antidepressant, but it has side effects like unusual dreams and experiences. The drug AV-101 may have the same antidepressant effects but fewer side effects. Researchers want to see if it is effective and safe for people with major depressive disorder. Objective: - To see if the drug, AV-101 is safe and if it treats symptoms of major depressive disorder. Eligibility: - Adults ages 18-65 with major depression without psychotic features. Design: - Participants will be screened under a separate protocol. - Participants will stay in the hospital for 12-14 weeks. - Phase 1 (2-7 weeks): participants will stop taking their medicines then not take any for 2 weeks. They will have several scans and other procedures. - Phase 2 (6-7 weeks): 2 weeks each of study drug and placebo once a day, with 2 weeks of no drugs in between. - Participants will have: - Physical exams - Interviews - Frequent blood collection. A needle will place a small plastic tube in the arm. Some blood samples will be taken through this tube. - 2 spinal taps (optional). The back will be numbed. A needle will insert a catheter between back bones. That will be left in for up to 30 hours. Spinal fluid will be collected through it. - 5 scans. Participants will lie in a machine with a magnetic field. The machine takes pictures of the brain and brain chemicals. - At the end of the study, participants will have medical evaluation, questions, and blood tests. Some may continue treatment at the clinic. |
NCT03078322 ↗ | AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression | Completed | VistaGen Therapeutics, Inc. | Phase 2 | The study will evaluate the safety and efficacy of AV-101. |
NCT03583554 ↗ | Electrophysiological Biomarkers of AV-101 | Completed | Michael Debakey Veterans Affairs Medical Center | Phase 1/Phase 2 | 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. |
NCT03583554 ↗ | Electrophysiological Biomarkers of AV-101 | Completed | Michael E. DeBakey VA Medical Center | Phase 1/Phase 2 | 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. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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