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.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
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™.
详细描述
"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."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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)
排除标准
- •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
研究组 & 干预措施
Name: GOPRELTO®
Single topical dose administered via cottonoid pledgets for 20 minutes.
干预措施: GOPRELTO® (Drug)
Name: NUMBRINO™
Single topical dose administered via cottonoid pledgets for 20 minutes.
干预措施: NUMBRINO™ (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: 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
时间窗: Pre-dose to 24 hours post-dose
Mean change from baseline in systolic blood pressure (mmHg).
Change in Diastolic Blood Pressure From Pre-Dose
时间窗: Pre-dose to 24 hours post-dose
Mean change from baseline in diastolic blood pressure (mmHg).
Change in Heart Rate From Pre-Dose
时间窗: Pre-dose to 24 hours post-dose
Mean change from baseline in heart rate (beats per minute).
Change in Respiratory Rate From Pre-Dose
时间窗: Pre-dose to 24 hours post-dose
Mean change from baseline in respiratory rate (breaths per minute).
Change in Oxygen Saturation (SpO₂)
时间窗: Pre-dose to 24 hours post-dose
Mean change in pulse oximetry oxygen saturation (% SpO₂).
ECG QT Interval
时间窗: Pre-dose to 24 hours post-dose
Mean QT interval (milliseconds) obtained from 12-lead ECG.
ECG PR Interval
时间窗: Pre-dose to 24 hours post-dose
Mean PR interval (milliseconds).
ECG QRS Duration
时间窗: Pre-dose to 24 hours post-dose
Mean QRS duration (milliseconds).
Peak Plasma Concentration (Cmax) of Cocaine
时间窗: Day 1 (pre-dose to end of PK sampling)
Maximum observed plasma concentration of cocaine (ng/mL)
Time to Peak Concentration (Tmax) of Cocaine
时间窗: 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
时间窗: 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
时间窗: Day 1 (pre-dose to end of PK sampling)
AUC extrapolated to infinity (ng·hr/mL).
Plasma Half-Life (t½) of Cocaine
时间窗: Day 1 (pre-dose to end of PK sampling)
Elimination half-life (hours).
Apparent Clearance (CL/F) of Cocaine
时间窗: Day 1
Apparent plasma clearance (L/hour).
次要结局
未报告次要终点