An Open-label, Two-arm Study Evaluating Pharmacokinetics, Safety, and Tolerability of GOPRELTO and NUMBRINO Nasal Solutions in Pediatric Subjects Undergoing Nasal Diagnostic Procedures or Surgeries From ≥12 Years to <18 Years of Age.
Overview
- Phase
- Phase 3
- Intervention
- GOPRELTO®
- Conditions
- Not specified
- Sponsor
- Omnivium Pharmaceuticals LLC
- Enrollment
- 40
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events (TEAEs)
- Status
- Not Yet Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
This open-label, two-arm, single-dose clinical study evaluates the pharmacokinetics, safety, and tolerability of GOPRELTO® (cocaine hydrochloride nasal solution 4%) and NUMBRINO™ (cocaine hydrochloride nasal solution 4%) in pediatric subjects aged 12 to <18 years undergoing diagnostic procedures or surgeries on or through the nasal mucous membranes. Up to 20 subjects will receive GOPRELTO® and up to 20 will receive NUMBRINO™.
Detailed Description
"GOPRELTO® and NUMBRINO™ are FDA-approved in adults for induction of local anesthesia of the mucous membranes during diagnostic procedures and surgeries. This Phase IIIb study assesses PK, safety, and tolerability in pediatric subjects using weight-based dosing applied via cottonoid pledgets. Plasma samples will be collected for PK, and standard safety assessments including vital signs, ECGs, pulse oximetry, laboratory tests, and adverse events will be performed."
Investigators
Eligibility Criteria
Inclusion Criteria
- •• Age 12 to \<18 years
- •Weight ≥10th percentile; BMI ≥5th percentile
- •Oxygen saturation ≥98%
- •Undergoing nasal diagnostic procedure or surgery
- •Able to assent; parent/guardian able to provide consent
- •Use of acceptable contraception (if applicable)
Exclusion Criteria
- •History of seizure
- •Hypersensitivity to cocaine or ester anesthetics
- •Recent intranasal cocaine use
- •Positive drug screen
- •Use of prohibited medications (SSRIs, MAOIs, decongestants, stimulants, etc.)
- •Cardiovascular disease, abnormal ECG
- •Hepatic or renal disease
- •Nasal mucosa trauma preventing pledget placement
Arms & Interventions
Name: GOPRELTO®
Single topical dose administered via cottonoid pledgets for 20 minutes.
Intervention: GOPRELTO®
Name: NUMBRINO™
Single topical dose administered via cottonoid pledgets for 20 minutes.
Intervention: NUMBRINO™
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Day 1 through Day 8-10
Number of subjects experiencing at least one treatment-emergent adverse event after administration of study drug.
Change in Systolic Blood Pressure From Pre-Dose
Time Frame: Pre-dose to 24 hours post-dose
Mean change from baseline in systolic blood pressure (mmHg).
Change in Diastolic Blood Pressure From Pre-Dose
Time Frame: Pre-dose to 24 hours post-dose
Mean change from baseline in diastolic blood pressure (mmHg).
Change in Heart Rate From Pre-Dose
Time Frame: Pre-dose to 24 hours post-dose
Mean change from baseline in heart rate (beats per minute).
Change in Respiratory Rate From Pre-Dose
Time Frame: Pre-dose to 24 hours post-dose
Mean change from baseline in respiratory rate (breaths per minute).
Change in Oxygen Saturation (SpO₂)
Time Frame: Pre-dose to 24 hours post-dose
Mean change in pulse oximetry oxygen saturation (% SpO₂).
ECG QT Interval
Time Frame: Pre-dose to 24 hours post-dose
Mean QT interval (milliseconds) obtained from 12-lead ECG.
ECG PR Interval
Time Frame: Pre-dose to 24 hours post-dose
Mean PR interval (milliseconds).
ECG QRS Duration
Time Frame: Pre-dose to 24 hours post-dose
Mean QRS duration (milliseconds).
Peak Plasma Concentration (Cmax) of Cocaine
Time Frame: Day 1 (pre-dose to end of PK sampling)
Maximum observed plasma concentration of cocaine (ng/mL)
Time to Peak Concentration (Tmax) of Cocaine
Time Frame: Day 1 (pre-dose to end of PK sampling)
Time to reach maximum plasma concentration (hours).
Area Under the Concentration-Time Curve (AUC₀-t) for Cocaine
Time Frame: Day 1 (pre-dose to end of PK sampling)
Area under the plasma concentration-time curve from time zero to last measurable concentration (ng·hr/mL).
Area Under the Concentration-Time Curve (AUC₀-∞) for Cocaine
Time Frame: Day 1 (pre-dose to end of PK sampling)
AUC extrapolated to infinity (ng·hr/mL).
Plasma Half-Life (t½) of Cocaine
Time Frame: Day 1 (pre-dose to end of PK sampling)
Elimination half-life (hours).
Apparent Clearance (CL/F) of Cocaine
Time Frame: Day 1
Apparent plasma clearance (L/hour).