Treatment of Topical Ketorolac Gel in Acute Gouty Flare

Summary

This study will be a phase 1, open-label, bioavailability, safety and PK study of topically applied transcutaneous ketorolac tromethamine gel 12.5% (/w) (NOV-1776) versus intravenous administration of approved ketorolac tromethamine injection, USP (15mg/mL) comparator in healthy volunteers, including an evaluation of safety, tolerability, and efficacy in gout participants with flare-up.

Timeline

Start

2024-02

Primary completion

2024-12

Completion

2024-12

Drugs

Indications