Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray

NCT ID: NCT02155309

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-03-31

Brief Summary

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.

Detailed 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.

Conditions

Motion Sickness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Scopolamine

0.2 mg intranasal scopolamine, single dose

Group Type: EXPERIMENTAL

Scopolamine

Intervention Type: DRUG

Placebo

placebo intranasal (0.1 mg per nostril), single dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Scopolamine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Repurposed Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Willliam J Becker, Phd

Role: PRINCIPAL_INVESTIGATOR

Naval Medical Research Unit - Dayton

Locations

Naval Medical Research Unit

Dayton, Ohio, United States

Countries

United States

References

Klocker N, Hanschke W, Toussaint S, Verse T. Scopolamine nasal spray in motion sickness: a randomised, controlled, and crossover study for the comparison of two scopolamine nasal sprays with oral dimenhydrinate and placebo. Eur J Pharm Sci. 2001 May;13(2):227-32. doi: 10.1016/s0928-0987(01)00107-5.

Reference Type: BACKGROUND

PMID: 11297908 (View on PubMed)

Other Identifiers

NAMRUD.2013.0004

Identifier Type: -

Identifier Source: org_study_id