An Open Label, Randomized, Single Center, Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine) in Opioid naïve, Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075.
研究概览
简要总结
The purpose of this study is to characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075 in two different, clinically-relevant dosing schedules.
详细描述
This study is an open label, randomized, two-treatment, two-period, two-sequence, single-center, crossover study comparing the pharmacokinetics, safety and tolerability of MNS075 (intranasal morphine) at doses of 7.5 mg self-administered q1h for 7 hours (8 doses) and 15 mg self-administered q3h for 9 hours (4 doses).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers 18 years of age or older
排除标准
- •History of alcohol, drug addiction, or substance abuse.
- •Known to or suspected to be currently abusing alcohol or drugs.
- •Allergy or hypersensitivity to shellfish or opioids.
- •History of seizures.
- •Clinically significant structural or functional abnormalities of the nose and upper airway, obstruction of the nasal passages, or mucosal lesions of the nostrils.
- •Smoked or used tobacco or nicotine products in the past six months or expects to during the study.
- •Positive for hepatitis B or hepatitis C or HIV antibodies.
研究组 & 干预措施
A
MNS075 7.5mg q1h
干预措施: MNS075 (Drug)
B
MNS075 15mg q3h
干预措施: MNS075 (Drug)
结局指标
主要结局
To characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075.
时间窗: Multiple
次要结局
未报告次要终点