drugset / Trial / NCT01483846
Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers
Phase 1
Completed
50 enrolled
VistaGen Therapeutics, Inc.
Cato Research · collabNational Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2011-12
- Primary completion
- 2012-09
- Completion
- 2012-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AV-101 | Small molecule | 360 mg | Oral |
| Subject | AV-101 | Small molecule | 1080 mg | Oral |
| Subject | AV-101 | Small molecule | 1440 mg | Oral |