NCT02155309

Pharmacokinetic and Efficacy Profile Intranasal Scopolamine Spray

Pharmacokinetic and Efficacy Profile of Low-Dose Intranasal Scopolamine Spray for Motion Sickness

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Repurposed Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Scopolamine
DRUG	Placebo

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-06-04
• Last updated: 2018-01-17
• Results posted: 2018-01-17

Locations

1 site across 1 country: United States