Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray
Stopped early · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Motion Sickness
In brief
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.
Key facts
- Study ID
- NCT02155309
- Run by
- Repurposed Therapeutics, Inc.
- People needed
- 63
- Starts
- 2014-06-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2018-01-17
Who can join
Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Naval Medical Research Unit — Dayton, Ohio, United States
Full record on ClinicalTrials.gov
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