Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal … (NCT04792034) | Clinical Trial Compass
RecruitingPhase 3
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
United States40 participantsStarted 2025-12-06
Plain-language summary
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.
Who can participate
Age range12 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Is accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.
✓. Is able to understand and provide assent to an age-appropriate subject assent form (as defined by local practice or regulation).
✓. Subject or parent/guardian is able to communicate with the Investigator and comply with the requirements of the protocol.
✓. Is male or female ≥12 to \<18 years of age at the time of dosing.
✓. Is no lower than the 10th percentile for weight according to age.
✓. Has a body mass index (BMI) no lower than the 5th percentile by age.
✓. Has an oxygen saturation of at least 98%.
✓. Will be undergoing a diagnostic procedure or surgery on or through the nasal mucous membranes of either one or both nostrils.
Exclusion criteria
✕. Has a history of seizure.
✕. Has a known hypersensitivity allergy to any ester-based anesthetics including cocaine hydrochloride, procaine, tetracaine, chloroprocaine, dibucaine, or benzocaine, and/or any other compounds of the drugs and /or devices that are part of this protocol (amide based anesthetics are NOT exclusionary).
✕. Has previously received intranasal topical cocaine within 14 days prior to the Screening Visit.
What they're measuring
1
Changes in Blood pressure
Timeframe: Baseline and every 5 minutes through 90 minutes post-pledget application.
2
Changes in Heart rate
Timeframe: Baseline and every 5 minutes through 90 minutes post-pledget application.
3
Changes in Respiratory Rate
Timeframe: Baseline and every 15 minutes through 90 minutes post-pledget application.
4
Physical examination
Timeframe: Screening Visit
5
Electrocardiogram
Timeframe: Screening Visit, and on Day 1 at Baseline (pre-dose), continuously during treatment, and through 90 minutes post-pledget application
6
Pulse Oximetry
Timeframe: Screening Visit, and on Day 1 at Baseline (pre-dose), continuously during treatment, and through 90 minutes post-pledget application
7
Incidence of Adverse events (AEs)
Timeframe: From Day 1 (pledget application) through the final follow-up call at Day 10.
. Has participated in an investigational study or received an investigational drug within 30 days preceding Treatment Day 1.
✕. Has a history of abuse of controlled substances, nasal or otherwise.
✕. Has a positive test result for drugs of abuse at the Screening Visit: amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates, and oxycodone via a urine test. Alcohol is prohibited within 24 hours prior to Treatment Day 1.
✕. Is a pregnant female or nursing mother or has a positive urine pregnancy test at the Screening Visit or on Treatment Day 1.
✕. Use of any serotonin-norepinephrine reuptake inhibitors/selective serotonin reuptake inhibitors (SNRIs/SSRIs) up to 14 days prior to the Screening Visit or has a need to use these drugs at any time throughout the duration of the study.
Maximum observed plasma concentration (Cmax)
Timeframe: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
9
Time to maximum observed plasma concentration (Tmax)
Timeframe: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
10
Area under the plasma concentration versus time curve from time of dosing (0) to the time of last quantifiable concentration (AUClast)
Timeframe: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
11
Area under the plasma concentration versus time curve from time of dosing (0) to infinity (AUCinf)
Timeframe: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
12
Terminal rate constant in plasma from the negative of the regression line slope through the ln plasma concentration versus time data defining the terminal phase [kel (λz)]
Timeframe: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
13
Terminal half-life in plasma calculated from the kel as ln(2)/kel (t½)
Timeframe: Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.