NCT04181008

Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, open-label study of the plasma pharmacokinetics of amiloride nasal spray at three different doses in healthy volunteers.

Detailed description

In this clinical study, we will evaluate the plasma pharmacokinetics of amiloride nasal spray in healthy volunteers at three different doses. The data obtained from this study will provide us with pharmacokinetic information that will help develop dosing regimens for future clinical efficacy studies in anxiety patients. Currently, there is no information on the bioavailability and pharmacokinetics of amiloride in humans after intranasal administration. All participants will be allowed to self-administer amiloride nasal spray at 0.2, 0.4, and 0.6 mg doses of amiloride. A series of timed blood samples (0,10, 15, 30, 60 minutes, and 4, 6, 8, 12 and 24 hours,1mL each time point) will be collected. Primary objectives: 1. To evaluate the pharmacokinetics of amiloride nasal spray at three different doses 0.2, 0.4, and 0.6 mg in healthy human volunteers. 2. To calculate the following pharmacokinetic parameters after intranasal administration of amiloride: time to reach maximum plasma concentration (Tmax), maximum plasma concentration (Cmax), area under the curve (AUC), the volume of distribution (Vd) and clearance (CL).

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Amiloride	Amiloride Nasal Spray
DRUG	Amiloride	Amiloride Nasal Spray
DRUG	Amiloride	Amiloride Nasal Spray

Timeline

• Start date: 2020-09-28
• Primary completion: 2022-08-30
• Completion: 2023-03-06
• First posted: 2019-11-29
• Last updated: 2023-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study