Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers

NCT04181008 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 126328
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (9)

• amiloride plasma concentration

  10 minutes

• amiloride plasma concentration

  15 minutes

• amiloride plasma concentration

  30 minutes

• amiloride plasma concentration

  60 minutes

• amiloride plasma concentration

  2 hours

• amiloride plasma concentration

  4 hours

• amiloride plasma concentration

  6 hours

• amiloride plasma concentration

  8 hours

• amiloride plasma concentration

  24 hours

Study Arms (3)

0.2 mg

EXPERIMENTAL

Drug: Amiloride

0.4 mg

EXPERIMENTAL

Drug: Amiloride

0.6 mg

EXPERIMENTAL

Drug: Amiloride

Interventions

Amiloride DRUG

Amiloride Nasal Spray

Also known as: Midamor

0.2 mg

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Center for Addiction and Mental Health: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (18)

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  PMID: 29396481 BACKGROUND

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Related Links

• Amiloride Hydrochloride, Drug Label Information
• FDA Approval of SPRAVATO™ (esketamine) CIII Nasal Spray for Adults with Treatment-Resistant Depression

MeSH Terms

Interventions

Amiloride

Intervention Hierarchy (Ancestors)

Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Venkata K Yellepeddi, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Clinical Pharmacology

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 29, 2019
• Study Start: September 28, 2020
• Primary Completion: August 30, 2022
• Study Completion: March 6, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)