Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers

November 1, 2022 updated by: Venkata Yellepeddi, University of Utah
This study is a single-center, open-label study of the plasma pharmacokinetics of amiloride nasal spray at three different doses in healthy volunteers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males between 18 to 30 years of age.
  • Females between 18 to 30 years of age.
  • Provide written informed consent and authorization.
  • Study participants must be able to complete consent, all study evaluations, olfactory testing, and study-related health questionnaires written in the English language.

Exclusion Criteria:

  • History of chronic drug, or narcotic abuse.
  • Chronic use of tranquilizers, sedatives, aspirin, antibiotics, or other medications.
  • Non-English speaking / English translation services required
  • Unwilling or unable to provide informed, written consent.
  • History or presence of major organ dysfunction.
  • History of malignancy, stroke, or diabetes; cardiac, renal, liver, or severe gastrointestinal disease; or other serious illness.
  • History of conditions which might contraindicate or require caution be used in the administration of amiloride including hyperkalemia with elevated serum potassium levels (greater than 5.5 mEq per liter), currently receiving other potassium-conserving agents such as spironolactone or triamterene, currently receiving potassium supplementation in the form of medication, potassium-containing salt substitutes or a potassium-rich diet, history or diagnosis of hypersensitivity to Amiloride.
  • Subjects with abnormal kidney function tests [estimated glomerular filtration (eGFR) - < 60, and albumin to creatinine ratio (ACR) - > 30]
  • Female subjects who are pregnant or nursing at the time of screening.
  • Subjects who underwent any kind of surgery of nose and septum within the past one year.
  • Subjects diagnosed with chronic rhinosinusitis.
  • Treatment with any other investigational drug during the 30 days prior to enrollment into the study.
  • Subjects who smoke, have a history of smoking or use nicotine-containing products.
  • Subjects who have donated blood within 30 days prior to study entry, including that withdrawn during the conduct of any other clinical study.
  • Subjects presenting with acute illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.2 mg
Drug: Amiloride
Amiloride Nasal Spray
Other Names:
  • Midamor
Experimental: 0.4 mg
Drug: Amiloride
Amiloride Nasal Spray
Other Names:
  • Midamor
Experimental: 0.6 mg
Drug: Amiloride
Amiloride Nasal Spray
Other Names:
  • Midamor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
amiloride plasma concentration
Time Frame: 10 minutes
10 minutes
amiloride plasma concentration
Time Frame: 15 minutes
15 minutes
amiloride plasma concentration
Time Frame: 30 minutes
30 minutes
amiloride plasma concentration
Time Frame: 60 minutes
60 minutes
amiloride plasma concentration
Time Frame: 2 hours
2 hours
amiloride plasma concentration
Time Frame: 4 hours
4 hours
amiloride plasma concentration
Time Frame: 6 hours
6 hours
amiloride plasma concentration
Time Frame: 8 hours
8 hours
amiloride plasma concentration
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Center for Addiction and Mental Health

Investigators

  • Principal Investigator: Venkata K Yellepeddi, PhD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2020

Primary Completion (Actual)

August 30, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

November 26, 2019

First Posted (Actual)

November 29, 2019

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 126328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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