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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06273813




Registration number
NCT06273813
Ethics application status
Date submitted
15/02/2024
Date registered
23/02/2024
Date last updated
23/02/2024

Titles & IDs
Public title
Treatment of Topical Ketorolac Gel in Acute Gouty Flare
Scientific title
A Phase 1 Safety, Tolerability and Pharmacokinetic Study of NOV-1776 Compared to Ketorolac Tromethamine IV in Adult Healthy Volunteers and Gout Patients
Secondary ID [1] 0 0
NOV-1776-CL-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Gouty Arthritis 0 0
Acute Pain 0 0
Gout Flare 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ketorolac Tromethamine 15 MG/ML
Treatment: Drugs - Ketorolac Tromethamine

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


Treatment: Drugs: Ketorolac Tromethamine 15 MG/ML
Single intravenous administration of Ketorolac Tromethamine injection in Cohort 1 on day 1

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Timepoint [1] 0 0
15 days
Primary outcome [2] 0 0
Area Under the Plasma Concentration Versus Time Curve (AUC) of topical ketorolac tromethamine
Timepoint [2] 0 0
15 days

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Paratus Clinical, - Blacktown
Recruitment hospital [2] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novilla Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06273813
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novotech CRO
Address 0 0
Novotech
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novotech CRO
Address 0 0
Country 0 0
Phone 0 0
+61 2 8569 1400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06273813