Treatment of Topical Ketorolac Gel in Acute Gouty Flare (NCT06273813) | Clinical Trial Compass
UnknownPhase 1
Treatment of Topical Ketorolac Gel in Acute Gouty Flare
Australia30 participantsStarted 2024-02
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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
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 (h…
What they're measuring
1
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Timeframe: 15 days
2
Area Under the Plasma Concentration Versus Time Curve (AUC) of topical ketorolac tromethamine