Clinical trial NCT04181008: Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
Official title: Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pharmacokinetics
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Center for Addiction and Mental Health
First posted: 2019-11-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: amiloride plasma concentration
timeFrame: 10 minutes
measure: amiloride plasma concentration
timeFrame: 15 minutes
measure: amiloride plasma concentration
timeFrame: 30 minutes
measure: amiloride plasma concentration
timeFrame: 60 minutes
measure: amiloride plasma concentration
timeFrame: 2 hours
measure: amiloride plasma concentration
timeFrame: 4 hours
measure: amiloride plasma concentration
timeFrame: 6 hours
measure: amiloride plasma concentration
timeFrame: 8 hours
measure: amiloride plasma concentration
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Venkata K Yellepeddi, PhD
role: PRINCIPAL_INVESTIGATOR
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