Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray

Phase 3TerminatedNCT02155309

Repurposed Therapeutics, Inc.63 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Motion Sickness

Interventions

ScopolamineDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Naval Medical Research Unit

Dayton, Ohio, United States

Outcomes

Primary Outcomes

Efficacy: Number of Head Movements During Rotation

During rotation, efficacy is measured by the number of head movements subjects are able to make (12 per minute). While seated yaw-axis rotating, a pre-recorded computerized voice informed subjects to make paced head tilts of 30 ̊ to the right and left at a rate of 0.125 Hz (right, center, left, and back to center over 16 seconds).

Time frame: 40 min

Data from ClinicalTrials.gov

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