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AV-101 for Drug Interaction

Phase 1
Waitlist Available
Research Sponsored by VistaGen Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Study Summary

This trial is testing a new drug, AV-101, to see how it is affected by probenecid and how it affects the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma and CSF concentrations of 4-chloro-kynurenine (AV-101) in ng/ml
Plasma and CSF concentrations of 7-chloro-kynurenic acid (7-Cl-KYNA) in ng/ml

Side effects data

From 2015 Phase 3 trial • 242 Patients • NCT01320722
13%
Abdominal discomfort
8%
Fatigue
8%
Decreased appetite
6%
Altered taste
6%
Joint pain
6%
Elevated liver enzymes
6%
Elevated creatinine
6%
Nausea
4%
Transient shortness of breath
4%
Dizziness
4%
Headache
4%
Tingling in extremities
2%
Transient nose bleed
2%
Sleepiness
2%
Sensitivity to touch
2%
Diarrhea
2%
Heartburn
2%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Allopurinol
Vitamin D
Placebo- Vitamin D
Probenecid
Placebo- Uric Acid

Trial Design

2Treatment groups
Experimental Treatment
Group I: AV-101 + ProbenecidExperimental Treatment2 Interventions
AV-101 360 mg oral capsules + 1000 mg Probenecid
Group II: AV-101Experimental Treatment1 Intervention
AV-101 360 mg oral capsules single dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probenecid
FDA approved
AV-101
Not yet FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ParexelIndustry Sponsor
304 Previous Clinical Trials
101,128 Total Patients Enrolled
VistaGen Therapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
1,561 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
AV-101 Alone and in Combination With Probenecid in Healthy Subjects
2021. "AV-101 Alone and in Combination With Probenecid in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05280054.
~7 spots leftby Apr 2025
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