Share
Save
Treatment of Topical Ketorolac Gel in Acute Gouty Flare
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-02-01
Primary completion: 2024-12-01
Study completion finish: 2024-12-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06273813
Intervention or treatment
DRUG: Ketorolac Tromethamine 15 MG/ML
DRUG: Ketorolac Tromethamine
Conditions
- • Acute Gouty Arthritis
- • Acute Pain
- • Gout Flare
Find a site
Closest Location:
Paratus Clinical,
Research sites nearby
Select from list below to view details:
Paratus Clinical,
Blacktown, Not Specified, Australia
Linear Clinical Research Ltd
Nedlands, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Ketorolac tromethamine
| DRUG: Ketorolac Tromethamine 15 MG/ML
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | Assessment of adverse events | 15 days |
Area Under the Plasma Concentration Versus Time Curve (AUC) of topical ketorolac tromethamine | Assessment of bioavailability of topical ketorolac tromethamine | 15 days |
Secondary outcome
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!