Pharmacokinetics, Safety, and Tolerability of GOPRELTO and NUMBRINO in Pediatric Nasal Procedures

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.

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™.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasal Procedures; Nasal Anesthesia; Nasal Mucosa Surgery
• Intervention / Treatment: Drug: GOPRELTO®; Drug: 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."

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dr. Robert Puchalski, Principal Investigator, MD; Phone Number: (803) 549-2467 South Carolina ENT, Allergy &; Email: rpuchalski@southcarolinaent.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Name: GOPRELTO®; Single topical dose administered via cottonoid pledgets for 20 minutes.	Drug: GOPRELTO®; cocaine hydrochloride nasal solution 4%
Experimental: Name: NUMBRINO™; Single topical dose administered via cottonoid pledgets for 20 minutes.	Drug: NUMBRINO™; cocaine hydrochloride nasal solution 4%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs)	Number of subjects experiencing at least one treatment-emergent adverse event after administration of study drug.	Day 1 through Day 8-10
Change in Systolic Blood Pressure From Pre-Dose	Mean change from baseline in systolic blood pressure (mmHg).	Pre-dose to 24 hours post-dose
Change in Diastolic Blood Pressure From Pre-Dose	Mean change from baseline in diastolic blood pressure (mmHg).	Pre-dose to 24 hours post-dose
Change in Heart Rate From Pre-Dose	Mean change from baseline in heart rate (beats per minute).	Pre-dose to 24 hours post-dose
Change in Respiratory Rate From Pre-Dose	Mean change from baseline in respiratory rate (breaths per minute).	Pre-dose to 24 hours post-dose
Change in Oxygen Saturation (SpO₂)	Mean change in pulse oximetry oxygen saturation (% SpO₂).	Pre-dose to 24 hours post-dose
ECG QT Interval	Mean QT interval (milliseconds) obtained from 12-lead ECG.	Pre-dose to 24 hours post-dose
ECG PR Interval	Mean PR interval (milliseconds).	Pre-dose to 24 hours post-dose
ECG QRS Duration	Mean QRS duration (milliseconds).	Pre-dose to 24 hours post-dose
Peak Plasma Concentration (Cmax) of Cocaine	Maximum observed plasma concentration of cocaine (ng/mL)	Day 1 (pre-dose to end of PK sampling)
Time to Peak Concentration (Tmax) of Cocaine	Time to reach maximum plasma concentration (hours).	Day 1 (pre-dose to end of PK sampling)
Area Under the Concentration-Time Curve (AUC₀-t) for Cocaine	Area under the plasma concentration-time curve from time zero to last measurable concentration (ng·hr/mL).	Day 1 (pre-dose to end of PK sampling)
Area Under the Concentration-Time Curve (AUC₀-∞) for Cocaine	AUC extrapolated to infinity (ng·hr/mL).	Day 1 (pre-dose to end of PK sampling)
Plasma Half-Life (t½) of Cocaine	Elimination half-life (hours).	Day 1 (pre-dose to end of PK sampling)
Apparent Clearance (CL/F) of Cocaine	Apparent plasma clearance (L/hour).	Day 1

Collaborators and Investigators

• Sponsor: Omnivium Pharmaceuticals LLC

Publications and helpful links

Helpful Links

• Full Prescribing Information - GOPRELTO®
• Full Prescribing Information - NUMBRINO™

Study record dates

Study Major Dates

• Study Start (Estimated): December 6, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 25, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: GOPRELTO; NUMBRINO; Cocaine Hydrochloride Nasal Solution; Pediatric Local Anesthesia
• Other Study ID Numbers: RA-VP-000-357; IND118527 and IND 106499 (Other Identifier: U.S. IND number for each investigational product.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No