Treatment of Topical Ketorolac Gel in Acute Gouty Flare

NCT06273813 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: NOV-1776-CL-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Acute Gouty Arthritis; Acute Pain; Gout Flare

Keywords

ketorolac; topical; intravenous

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Ketorolac tromethamine

EXPERIMENTAL

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; Drug: Ketorolac Tromethamine

Interventions

Ketorolac Tromethamine 15 MG/ML DRUG

Single intravenous administration of Ketorolac Tromethamine injection in Cohort 1 on day 1

Ketorolac tromethamine

Ketorolac Tromethamine DRUG

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

Ketorolac tromethamine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohorts 1 and 2
• 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
• Cohort 3 - additional requirements
• \- Medical diagnosis of gout for at least 2 years and1 - 2 acute gout flare-ups within the last 12 months

You may not qualify if:

• Cohorts 1. 2 and 3
• 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.

Sponsors & Collaborators

• Novilla Pharmaceuticals: lead

Study Sites (2)

Paratus Clinical,

Blacktown, 2148, Australia

Location

Linear Clinical Research Ltd

Nedlands, 6009, Australia

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Novotech CRO

  Novotech

  STUDY DIRECTOR

Central Study Contacts

Novotech CRO

CONTACT

+61 2 8569 1400; info@novotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All cohost 1 subjects receive single ketorolac tromethamine injection, followed by escalating doses of ketorolac tromethamine gel Cohort 2 and 3 subjects receive doses of ketorolac tromethamine gel for 5 days

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 23, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

AU (2)