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Treatment of Topical Ketorolac Gel in Acute Gouty Flare

PHASE1NOT_YET_RECRUITING

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.

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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.

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Eligibility criteria

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Inclusion criteria

Evidence of a personally signed and dated informed consent form (ICF) in English

Healthy study participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Body mass index (BMI) from 18.0 to 32.0 kg/m2, inclusive; and body weight of at least 50 kg (110 lbs) and Resting supine systolic blood pressure from 90 to 140 mmHg and supine diastolic blood pressure from 40 to 90 mmHg

Male participants must agree to utilize a barrier contraceptive method for the duration of the study and agree to avoid sperm donation for at least 90 days after completing study participation and female participants must be of non-childbearing potential (defined as either surgically sterile or at least 1 year post-menopausal; post-menopausal is defined as no menses for 12 months and confirmed by FSH level ≥ 40 mIU/mL); or must be using a highly effective method of contraception

Medical diagnosis of gout for at least 2 years and 1 - 2 acute gout flare-ups within the last 12 months

Exclusion criteria

Presence or history of any disorder that may prevent the successful completion of Cohort 1 [or Cohort 2, as appropriate]

Allergy or sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), ketorolac tromethamine, or any components of the formulation and /or history of significant allergies and hypersensitivity reactions (hives, breathing difficulty, etc.) to aspirin or any other medications, either prescription or nonprescription, including dietary supplements or herbal medications.

A clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, gastrointestinal (e.g., bleeding, ulcers, perforation), cardiovascular (e.g., cardiovascular thrombotic events, myocardial infarction, stroke) pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous system, hematologic system (e.g., bleeding disorders), psychiatric disease, seizure, epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions, or recent surgery that the Investigator deems clinically significant.

History or recent occurrence of clinically significant skin disorders (including photosensitivity reactions, eczema, and psoriasis) or any surgical or medical condition or skin modification at the site of drug application that may interfere with the absorption, distribution, metabolism or excretion of the test article.

Hemoglobin < 13.2 g/dL or < 132 g/L (males) and < 11.7 g/dL or < 117 g/L (females); Hematocrit < 38.5% (males) and < 35% (females) platelet count < 100,000 platelets per microliter (males and females); at Screening

Uncontrolled hypertension with consistent blood pressure higher than 140 / 90 mmHg.

within 7 days prior to study enrollment, acute illness (e.g., nausea, vomiting, fever, or diarrhea), use of any prescription OTC or dietary or herbal supplements, including ketorolac tromethamine

within 60 days prior to study enrollment, plasma or blood donation

within 90 days prior to study enrollment, use of hepatic or renal clearance altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, St. John's Wort, etc.)

Positive finding on urine drug screen ( (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine, methadone, and opiates or other substances deemed inappropriate); Positive serological findings for any of the following: Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, Hepatitis C antibody, or Hepatitis A IgM tests at Screening.

Female participants who are pregnant or breastfeeding.

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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

Condition: Acute Gouty Arthritis, Acute Pain and more
DRUG: Ketorolac Tromethamine 15 MG/ML and other drugs
Blacktown, Not Specified, Australia and more
Sponsor: Novilla Pharmaceuticals

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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 Cohort 1 - All subjects receive one Ketorolac tromethamine injection, followed by Ketorolac tromethamine gel topical Cohort 2 and 3 - Ketorolac tromethamine gel topical	DRUG: Ketorolac Tromethamine 15 MG/ML Single intravenous administration of Ketorolac Tromethamine injection in Cohort 1 on day 1

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

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References

Clinical Trials Gov: Treatment of Topical Ketorolac Gel in Acute Gouty Flare