| Eligibility |
Inclusion Criteria:
1. Ability to provide written, informed consent prior to initiation of any study-related
procedures, and ability in the opinion of the Investigator to understand and comply
with all the requirements of the study, which includes abstaining from the use of
prohibited medications.
2. Male and female participants, aged 18 to 70 years of age (inclusive);
3. Minimally susceptible to provocative motion as evidenced by at least two responses on
the (MSSQ-short) of "Sometimes" or "Frequently";
4. Acceptable overall medical condition to be safely enrolled in and complete the study
in the opinion of the Investigator;
5. Ability to take intranasal medication;
6. Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months
before screening or participant is 2 years postmenopausal), or females of childbearing
potential using an acceptable method of birth control (i.e., condoms, diaphragm,
spermicidal agents, cervical cap, copper intrauterine device, etc.) for a period of up
to 30 days before dosing and for one month after dosing and must have a negative
pregnancy test at screening;
7. Agree to adhere to the following lifestyle compliance considerations:
1. Refrain from consumption of grapefruit and any substance containing grapefruit
for 7 days prior to, during, and 7 days after study drug administration;
2. Abstain from alcohol for 24 hours prior to the administration of study drug and
through the ocean travel;
3. Abstain from marijuana within the 7-day period prior to the Treatment Day and
throughout Day 3..
8. Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) negative test, confirmed
by Food and Drug Administration (FDA) authorized COVID-19 test < 7 days prior to study
drug administration or no COVID 19 symptoms up to 10 days prior to study drug
administration.
Exclusion Criteria:
Main Criteria for Exclusion:
1. Nauseated prior to boarding.
2. Mini-Mental State Examination score of <24;
3. Women of childbearing potential, or men whose sexual partner(s) is a woman of
childbearing potential, who:
1. Are or intend to become pregnant (including use of fertility drugs) during the
study;
2. Are nursing (female participants only);
3. Are not using an acceptable, highly effective method of contraception until all
follow-up procedures are complete.
4. Known allergic reactions to scopolamine or other anticholinergics;
5. Hospitalization or significant surgery requiring hospital admittance within the past 6
months;
6. Treatment with another investigational product within the past 30 days;
7. Donated blood or plasma or suffered significant blood loss within the past 30 days;
8. Chronic nausea caused by conditions such as irritable bowel syndrome, gastroparesis,
cyclic vomiting syndrome or any other cause;
9. Having any of the following medical conditions within the last 2 years or if any of
the following medical conditions were experienced more than 2 years ago and are deemed
as clinically significant by the Investigator:
1. Significant gastrointestinal disorder, asthma, or seizure disorders;
2. History or current cardiovascular disease;
3. History or current vestibular disorders;
4. History or current narrow-angle glaucoma;
5. History or current urinary retention problems;
6. History or current alcohol or drug abuse;
7. History or current nasal, nasal sinus or nasal mucosa surgery.
10. Currently taking any of the following medication types within the specified washout
period:
1. Any form of scopolamine (including Transderm Scop®/washout 5 days;
2. Belladonna alkaloids/washout 14 days;
3. Antihistamines (including meclizine/washout 14 days;
4. Tricyclic antidepressants/washout 14 days;
5. Muscle relaxants/washout 4 days, and;
6. Nasal decongestants/washout 4 days.
11. Has used marijuana within the 7-day period prior to the Treatment Day. (Note: this
criterion will only be confirmed at Eligibility Confirmation, not at Recruitment and
Screening, although heavy users of marijuana can be determined ineligible at
Screening. All potential study participants deemed eligible at Screening must be
informed at that time that this requirement must be met at Eligibility Confirmation.)
12. Unwilling or unable to follow the medication restrictions or unwilling to wash-out the
use of restricted medications as noted in Exclusion 10.
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