CLINICAL TRIALS PROFILE FOR AV-101
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Clinical Trials for AV-101
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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