NCT06273813

Treatment of Topical Ketorolac Gel in Acute Gouty Flare

A Phase 1 Safety, Tolerability and Pharmacokinetic Study of NOV-1776 Compared to Ketorolac Tromethamine IV in Adult Healthy Volunteers and Gout Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Novilla Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants will be in the age range of 18 - 64 years of age (Cohort 1) and 18 - 70 years of age (Cohorts 2 and 3). This study will be conducted in three consecutive cohorts (see Figure 1). Cohorts 1 and 2 is conducted inpatient, while Cohort 3 is conducted outpatient. \- Cohort 1: Open-label, single-day, multiple-dose (three doses), in approximately 8 adult healthy volunteers. Study participants will be admitted to the clinic and receive one intravenous dose of ketorolac tromethamine injection, USP over the course of one day for one treatment period, and three doses of topical drug product over the course of 1 day, 6 hours apart for each of 3 subsequent treatment periods of this Cohort 1. The next dose begins after a 2-day wash-out period, and there are three dose levels for the topically applied transcutaneous ketorolac tromethamine gel 12.5% (w/w) (NOV-1776) to be compared to one intravenous administration of 2 ml of ketorolac tromethamine injection, USP (5 mg/mL). Safety Review Committee meeting to review Cohort 1 data and approve continuance to Cohort 2. * Cohort 2: Open-label, 1-arm, 5-day, multiple-dose PK, safety in approximately 12 adult healthy volunteers at the maximum tolerated dose demonstrated by Cohort 1. Study participants will be admitted to the clinic and receive three doses of drug product, 6 hours apart, over the course of 5 days. Cohort 1 participants are eligible to participate in Cohort 2. Safety Review Committee meeting to review Cohort 1 and 2 data and approve continuance to Cohort 3. * Cohort 3 will be an open-label, 1-arm, 5-day, multiple-dose safety, toleration, and efficacy design in 10 adult gout participants with flare-up

Conditions

• Acute Gouty Arthritis
• Acute Pain
• Gout Flare

Interventions

Type	Name	Description
DRUG	Ketorolac Tromethamine 15 MG/ML	Single intravenous administration of Ketorolac Tromethamine injection in Cohort 1 on day 1
DRUG	Ketorolac Tromethamine	Three doses of topical ketorolac tromethamine over the course of 1 day, 6 hours apart for each of 3 subsequent treatment periods in cohort 1 Three doses of Ketorolac Tromethamine, 6 hours apart, over the course of 5 days in cohorts 2 and 3

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-02-23
• Last updated: 2024-02-23

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study