Actively Recruiting
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
Led by Noden Pharma · Updated on 2025-12-26
40
Participants Needed
4
Research Sites
107 weeks
Total Duration
On this page
Sponsors
N
Noden Pharma
Lead Sponsor
O
Omnivium Pharmaceuticals LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to assess the pharmacokinetic (PK) properties, safety and tolerability following a single dose administration of GOPRELTO® or NUMBRINO™ as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities in pediatric adolescent subjects.
CONDITIONS
Official Title
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is aged 12 to under 18 years at dosing.
- Participant is accompanied by a parent or guardian able to understand and sign consent.
- Participant can provide age-appropriate assent.
- Participant or guardian can communicate with the investigator and follow study rules.
- Participant's weight is at least the 10th percentile for age.
- Participant's body mass index (BMI) is at least the 5th percentile for age.
- Participant has an oxygen saturation of at least 98%.
- Participant will undergo a diagnostic or surgical procedure involving nasal mucous membranes.
- Female participants who can become pregnant or sexually active males agree to use effective birth control from screening through 8 days after dosing.
You will not qualify if you...
- History of seizures.
- Known allergy to ester-based anesthetics including cocaine hydrochloride and related compounds.
- Use of intranasal topical cocaine within 14 days before screening.
- Participation in an investigational drug study within 30 days before treatment.
- History of substance abuse.
- Positive urine test for drugs of abuse at screening.
- Pregnancy, nursing, or positive pregnancy test.
- Use of SNRIs/SSRIs or MAO inhibitors within 14 days before screening or planned use during the study.
- Use of certain nasal or stimulant products within 2 days before screening or planned use at treatment.
- Use of disulfiram.
- Planned use of additional vasoconstrictors like epinephrine.
- Conditions that compromise safety, data quality, or wound healing.
- Severe nasal mucosa trauma or damage preventing pledget insertion.
- Recent or active serious heart conditions or uncontrolled hypertension.
- Abnormal electrocardiogram findings excluding some sinus rhythms.
- Personal or family history of hereditary pseudocholinesterase deficiency or pheochromocytoma.
- Clinically significant abnormal lab results.
- History or current liver or kidney disease.
- Investigator judgment of unsuitability for study participation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
SCENT Sleep and Allergy, 110 Highland Center Drive
Columbia, South Carolina, United States, 29203
Actively Recruiting
2
SCENT Sleep and Allergy, 145 Park Central
Columbia, South Carolina, United States, 29203
Actively Recruiting
3
South Carolina ENT, Sleep and Allergy
Columbia, South Carolina, United States, 29212
Actively Recruiting
4
SCENT Sleep and Allergy, 15 Exchange Dr.
Lugoff, South Carolina, United States, 29078
Actively Recruiting
Research Team
R
Robert Puchlaski, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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