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Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04181008
Recruitment Status : Recruiting
First Posted : November 29, 2019
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Center for Addiction and Mental Health
Information provided by (Responsible Party):
Venkata Yellepeddi, University of Utah

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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: Amiloride Early Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.2 mg Drug: Amiloride
Amiloride Nasal Spray
Other Name: Midamor

Experimental: 0.4 mg Drug: Amiloride
Amiloride Nasal Spray
Other Name: Midamor

Experimental: 0.6 mg Drug: Amiloride
Amiloride Nasal Spray
Other Name: Midamor




Primary Outcome Measures :
  1. amiloride plasma concentration [ Time Frame: 10 minutes ]
  2. amiloride plasma concentration [ Time Frame: 15 minutes ]
  3. amiloride plasma concentration [ Time Frame: 30 minutes ]
  4. amiloride plasma concentration [ Time Frame: 60 minutes ]
  5. amiloride plasma concentration [ Time Frame: 2 hours ]
  6. amiloride plasma concentration [ Time Frame: 4 hours ]
  7. amiloride plasma concentration [ Time Frame: 6 hours ]
  8. amiloride plasma concentration [ Time Frame: 8 hours ]
  9. amiloride plasma concentration [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181008


Contacts
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Contact: Venkata K Yellepeddi, PhD 801-213-0701 venkata.yellepeddi@hsc.utah.edu

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Venkata K. Yellepeddi, Ph.D.    801-213-0701    venkata.yellepeddi@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Center for Addiction and Mental Health
Investigators
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Principal Investigator: Venkata K Yellepeddi, PhD University of Utah
Additional Information:
Publications:

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Responsible Party: Venkata Yellepeddi, Associate Professor, Division of Clinical Pharmacology, University of Utah
ClinicalTrials.gov Identifier: NCT04181008    
Other Study ID Numbers: 126328
First Posted: November 29, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amiloride
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing