Nebulizer Delivery of Intranasal Scopolamine

Study Overview
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Brief Summary
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To develop a better way to administer anti-motion sickness medications using an intranasal nebulizer.

Official Title
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Nebulizer Delivery of Intranasal Scopolamine

Conditions
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Scopolamine, Motion Sickness

Intervention / Treatment
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* Drug: Scopolamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Adults age 21-49 Normal weight for body size, based on BMI table General good health, as determined by a verbally provided medical history Normal brief neurological exam Renal and hepatic function within normal ranges Able to provide written informed consent to participate Exclusion Criteria: Drug allergies to scopolamine or other belladonna alkaloid Use of medications within 1 week of starting the study Use of an investigational drug within 30 days of starting the study Tobacco smoking within the past year Blood donation or significant blood loss within 30 days of starting the study Significant gastrointestinal disorder (e.g. Crohn's Disease, ulcerative colitis, chronic constipation), asthma, glaucoma, prostate problems, urinary obstruction, or seizure disorders History of alcohol or other drug abuse Pregnancy or suspected pregnancy, or lactation (pregnancy will be confirmed with urine pregnancy testing prior to drug administration) Consumption of grapefruit juice within 7 days of scopolamine (SCOP) administration Nasal, nasal sinus, or nasal mucosa surgery within 90 days prior to study initiation Other significant surgeries within 90 days Significant deviated septum that blocks air flow in one nostril Rhinitis, sinus infection, severe allergies, and other upper respiratory infections within 30 days prior to the study Current use of an intranasal medication Wheezing or other respiratory problem Unable to consent Prisoner

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pharmacokinetic study followed by double-blind, placebo-controlled, dose-ranging design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacokinetic<br>Participants receive 1 dose of Scopolamine 0.4 mg delivered via a intranasal nebulizer developed by Creare LLC. | Drug: Scopolamine<br>* Intranasal scopolamine at 0.2 mg or 0.4 mg<br>|
| Experimental: Chair<br>Participants receive 1 dose of Scopolamine 0.2 mg, 1 dose of Scopolamine 0.4 mg, and 1 dose of placebo saline delivered via the Creare LLC intranasal nebulizer. These dosages are all 1 week apart and the order is randomized. | Drug: Scopolamine<br>* Intranasal scopolamine at 0.2 mg or 0.4 mg<br>Drug: Placebo<br>* Intranasal saline placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to maximal concentration for scopolamine after intranasal administration (Tmax) | Plasma scopolamine concentrations will be measured using an liquid chromatography-mass spectrometry (LC- MS) assay. Tmax is measured in minutes to reach the maximum concentration. | Baseline, 180 minutes | 
| Side effects of intranasal scopolamine, as measured through a questionnaire with a subjective rating scale | A questionnaire will be administered asking about the participant's side effect profile after taking intranasal scopolamine. The questionnaire will have a subjective rating scale of 0-10 on the potential scopolamine side effects expected | 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness in reducing motion sickness as measured by duration of chair ride. | The degree of motion sickness will be assessed by measuring the total number of minutes the subject rides in the chair before stopping | Baseline, end of chair ride (maximum of 20 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scopolamine, Motion Sickness, Space Physiology