Phase 1, Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax)
研究概览
简要总结
To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. To also determine the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to determine the safety of intranasal naloxone with respect to nasal irritation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to provide written consent
- •Must have a BMI ranging from 18 to 30kg/m2, inclusive
- •Must have adequate venous access
- •Must not have any clinically significant concurrent medical conditions determine by medical history, physical examination, vital signs, and 12-lead electrocardiogram.
- •Must agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. Oral contraceptives are prohibited.
- •Must agree to not ingest alcohol, drinks containing xanthine greater than 500 mg/day (e.g., Coca Cola, coffee, tea, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.
排除标准
- •Please contact clinical site directly for more information
研究组 & 干预措施
2mg Intranasal Naloxone
Administer 0.1mL spray of the 20 mg/mL formulation in one nostril
干预措施: Naloxone (Drug)
4mg(a) Intranasal Naloxone
Administer 0.1mL spray of the 20 mg/mL formulation in both nostrils
干预措施: Naloxone (Drug)
4mg(b) Intranasal Naloxone
Administer 0.1mL spray of the 40mg/mL formulation in one nostril
干预措施: Naloxone (Drug)
8mg Intranasal Naloxone
Administer 0.1mL spray of the 40mg/mL formulation in both nostrils
干预措施: Naloxone (Drug)
Intramuscular Naloxone
Administer 1mL of 0.4mg/mL formulation intramuscularly
干预措施: Naloxone (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax)
时间窗: 720 minutes
Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration.
Time at Maximum Plasma Concentration (Tmax)
时间窗: 720 minutes
Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration
Area Under the Concentration (AUC 0-t)
时间窗: 720 minutes
Time curve from time zero to last measurable concentration. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration
Area Under Curve (AUC 0-inf)
时间窗: 720 minutes
Time curve from time zero to infinity. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration
Half-life
时间窗: 720 minutes
The apparent terminal exponential half-life. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration
次要结局
- Adverse events(minimum of 18 days)
- Vital Signs(480 minutes)
- 12-lead electrocardiogram(480 minutes)
- Nasal Irritation Scoring(24 hours)