Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray

Repurposed Therapeutics

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Motion Sickness

Treatments

Drug: Placebo

Drug: Scopolamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02155309

NAMRUD.2013.0004

Details and patient eligibility

About

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.

Full description

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.

Enrollment

63 patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

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