Pharmacokinetic and Efficacy Profile of Low-Dose Intranasal Scopolamine Spray for Motion Sickness
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Efficacy: Number of Head Movements During Rotation
研究概览
简要总结
Part 1, the pharmacokinetic (PK) phase, will expand upon the pilot study conducted at Naval Medical Research Laboratory (NAMRL) and has the goal of determining bioavailability and time to Cmax in a larger representative sample. Part 2, the efficacy phase, is to determine the efficacy of the aqueous spray solution via exposure to a nausea-inducing stimulus.
详细描述
Part 1: The pharmacokinetic (PK) phase Objective: To determine the bioavailability and amount of scopolamine absorbed after administration of 0.2 mg intranasal scopolamine at regular intervals across 8 hours post- dose.
Hypothesis
Detectable levels of Intranasal scopolamine (INSCOP) will be present in subject plasma within 15 minutes post-dose; mean time to Cmax (maximum plasma concentration) will be less than 1.5 hr.
Part 2: The Efficacy phase Objective: To determine the effectiveness, cognitive performance effects, and medication side-effect profile of 0.2 mg intranasal scopolamine spray as a motion sickness (MS) countermeasure.
Hypothesis
The primary hypothesis is that the INSCOP spray will be more efficacious against MS than placebo, without statistically significant cognitive performance side-effects. Specifically, participants will tolerate significantly more provocative head tilts in the INSCOP condition than in the placebo condition.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, 18 to 59 years old, inclusive, in good general health as determined by physical examination and without clinically significant laboratory profiles
- •Normal weight for body size, based on Physical Readiness Test Body Composition Assessment (PPRTBCA) table
- •Willing and able to comply with study requirements and restrictions; and read and sign the informed consent.
排除标准
- •Known and/or documented drug allergies, especially to scopolamine
- •Use of an investigational drug within 30 days of starting the study
- •Smoking or use of tobacco products, including "chew" or "snuff", within six months
- •Blood donation or significant blood loss within 30 days of starting the study
- •Significant gastrointestinal disorder, asthma, or seizure disorders
- •History of narrow-angle glaucoma
- •History of urinary retention problems
- •History of alcohol or other drug abuse
- •Pregnancy or suspected pregnancy, or lactation
- •Hematocrit values less than 41% for males and 37% for females
- •Recent nasal, nasal sinus or nasal mucosa surgery
- •Use of prescription, over-the-counter, or herbal medication in past 7 days
研究组 & 干预措施
Scopolamine
0.2 mg intranasal scopolamine, single dose
干预措施: Scopolamine (Drug)
Placebo
placebo intranasal (0.1 mg per nostril), single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy: Number of Head Movements During Rotation
时间窗: 40 min
During rotation, efficacy is measured by the number of head movements subjects are able to make (12 per minute). While seated yaw-axis rotating, a pre-recorded computerized voice informed subjects to make paced head tilts of 30 ̊ to the right and left at a rate of 0.125 Hz (right, center, left, and back to center over 16 seconds).
次要结局
未报告次要终点