Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray

Pharmacokinetic and Efficacy Profile of Low-Dose Intranasal Scopolamine Spray for Motion Sickness

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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