NCT05280054

AV-101 Alone and in Combination With Probenecid in Healthy Subjects

An Open-label, Drug Interaction Study to Evaluate Safety, Pharmacokinetic, and Pharmacodynamic Effect of Oral Administration of AV-101 Alone and in Combination With Probenecid in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: VistaGen Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, two period, fixed-sequence, drug-drug interaction study to compare the PK and PD of orally administered AV-101 alone and in combination with probenecid in healthy subjects. In Treatment Period 1, subjects will receive AV-101 following an overnight fast of at least 8 hours. In Treatment Period 2, subjects will fast overnight for at least 8 hours, and then receive AV-101 2 hours after receiving 1,000 mg probenecid. Each Treatment Period will be separated by a washout period. The doses of AV-101 in Cohort 1 and a possible Cohort 2 will be 360 mg and 720 mg, respectively. Optional Cohorts 3 and 4 may be enrolled depending on results from Cohorts 1 and 2. CSF will be collected via indwelling catheter to determine the PK of AV-101 and its active metabolite 7-Cl-KYNA.

Conditions

• Drug Drug Interaction

Interventions

Type	Name	Description
DRUG	AV-101	360 mg capsules
DRUG	Probenecid	1000 mg oral

Timeline

• Start date: 2021-12-23
• Primary completion: 2022-09-01
• Completion: 2022-11-01
• First posted: 2022-03-15
• Last updated: 2022-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study