Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 26, 2019
First Posted Date  ICMJE November 29, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE September 28, 2020
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
  • amiloride plasma concentration [ Time Frame: 10 minutes ]
  • amiloride plasma concentration [ Time Frame: 15 minutes ]
  • amiloride plasma concentration [ Time Frame: 30 minutes ]
  • amiloride plasma concentration [ Time Frame: 60 minutes ]
  • amiloride plasma concentration [ Time Frame: 2 hours ]
  • amiloride plasma concentration [ Time Frame: 4 hours ]
  • amiloride plasma concentration [ Time Frame: 6 hours ]
  • amiloride plasma concentration [ Time Frame: 8 hours ]
  • amiloride plasma concentration [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
Official Title  ICMJE Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE Drug: Amiloride
Amiloride Nasal Spray
Other Name: Midamor
Study Arms  ICMJE
  • Experimental: 0.2 mg
    Intervention: Drug: Amiloride
  • Experimental: 0.4 mg
    Intervention: Drug: Amiloride
  • Experimental: 0.6 mg
    Intervention: Drug: Amiloride
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 26, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Venkata K Yellepeddi, PhD 801-213-0701 venkata.yellepeddi@hsc.utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04181008
Other Study ID Numbers  ICMJE 126328
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Venkata Yellepeddi, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Center for Addiction and Mental Health
Investigators  ICMJE
Principal Investigator: Venkata K Yellepeddi, PhD University of Utah
PRS Account University of Utah
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP