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PharmacokineticsEarly Phase 1NCT04181008

Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers

A Early Phase 1 study testing Amiloride in people with Pharmacokinetics, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Pharmacokinetics
What is being tested?
Amiloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
28 Sep 2020to 6 Mar 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

This study is a single-center, open-label study of the plasma pharmacokinetics of amiloride nasal spray at three different doses in healthy volunteers.

Read the 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).
Being tested
Amiloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmilorideDrug

    Also called Midamor

    Amiloride Nasal Spray

  • AmilorideDrug

    Also called Midamor

    Amiloride Nasal Spray

  • AmilorideDrug

    Also called Midamor

    Amiloride Nasal Spray

Study groups in NCT04181008
Study groupRoleWhat they receive
0.2 mgExperimentalNot described
Receives: Drug: Amiloride
0.4 mgExperimentalNot described
Receives: Drug: Amiloride
0.6 mgExperimentalNot described
Receives: Drug: Amiloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. amiloride plasma concentration

    Measured: 10 minutes

  2. amiloride plasma concentration

    Measured: 15 minutes

  3. amiloride plasma concentration

    Measured: 30 minutes

  4. amiloride plasma concentration

    Measured: 60 minutes

  5. amiloride plasma concentration

    Measured: 2 hours

  6. amiloride plasma concentration

    Measured: 4 hours

  7. amiloride plasma concentration

    Measured: 6 hours

  8. amiloride plasma concentration

    Measured: 8 hours

  9. amiloride plasma concentration

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2019
  2. Study start28 Sep 2020
  3. Primary completion30 Aug 2022
  4. Study completion6 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04181008
Sponsor's protocol ID
126328
Status last verified
Mar 2023
First submitted
26 Nov 2019
Last updated
8 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Weissman MM, Klerman GL, Markowitz JS, Ouellette R. Suicidal ideation and suicide attempts in panic disorder and attacks. N Engl J Med. 1989 Nov 2;321(18):1209-14. doi: 10.1056/NEJM198911023211801.

    PubMed 2797086

  • Grant BF, Saha TD, Ruan WJ, Goldstein RB, Chou SP, Jung J, Zhang H, Smith SM, Pickering RP, Huang B, Hasin DS. Epidemiology of DSM-5 Drug Use Disorder: Results From the National Epidemiologic Survey on Alcohol and Related Conditions-III. JAMA Psychiatry. 2016 Jan;73(1):39-47. doi: 10.1001/jamapsychiatry.2015.2132.

    PubMed 26580136

  • Meuret AE, Rosenfield D, Wilhelm FH, Zhou E, Conrad A, Ritz T, Roth WT. Do unexpected panic attacks occur spontaneously? Biol Psychiatry. 2011 Nov 15;70(10):985-91. doi: 10.1016/j.biopsych.2011.05.027. Epub 2011 Jul 23.

    PubMed 21783179

  • Maddock RJ, Buonocore MH, Miller AR, Yoon JH, Soosman SK, Unruh AM. Abnormal activity-dependent brain lactate and glutamate+glutamine responses in panic disorder. Biol Psychiatry. 2013 Jun 1;73(11):1111-9. doi: 10.1016/j.biopsych.2012.12.015. Epub 2013 Jan 17.

    PubMed 23332354

  • Battaglia M, Pesenti-Gritti P, Medland SE, Ogliari A, Tambs K, Spatola CA. A genetically informed study of the association between childhood separation anxiety, sensitivity to CO(2), panic disorder, and the effect of childhood parental loss. Arch Gen Psychiatry. 2009 Jan;66(1):64-71. doi: 10.1001/archgenpsychiatry.2008.513.

    PubMed 19124689

  • Spatola CA, Scaini S, Pesenti-Gritti P, Medland SE, Moruzzi S, Ogliari A, Tambs K, Battaglia M. Gene-environment interactions in panic disorder and CO(2) sensitivity: Effects of events occurring early in life. Am J Med Genet B Neuropsychiatr Genet. 2011 Jan;156B(1):79-88. doi: 10.1002/ajmg.b.31144. Epub 2010 Nov 30.

    PubMed 21184587

  • D'Amato FR, Zanettini C, Lampis V, Coccurello R, Pascucci T, Ventura R, Puglisi-Allegra S, Spatola CA, Pesenti-Gritti P, Oddi D, Moles A, Battaglia M. Unstable maternal environment, separation anxiety, and heightened CO2 sensitivity induced by gene-by-environment interplay. PLoS One. 2011 Apr 8;6(4):e18637. doi: 10.1371/journal.pone.0018637.

    PubMed 21494633

  • Cittaro D, Lampis V, Luchetti A, Coccurello R, Guffanti A, Felsani A, Moles A, Stupka E, D' Amato FR, Battaglia M. Histone Modifications in a Mouse Model of Early Adversities and Panic Disorder: Role for Asic1 and Neurodevelopmental Genes. Sci Rep. 2016 Apr 28;6:25131. doi: 10.1038/srep25131.

    PubMed 27121911

  • Giannese F, Luchetti A, Barbiera G, Lampis V, Zanettini C, Knudsen GP, Scaini S, Lazarevic D, Cittaro D, D'Amato FR, Battaglia M. Conserved DNA Methylation Signatures in Early Maternal Separation and in Twins Discordant for CO2 Sensitivity. Sci Rep. 2018 Feb 2;8(1):2258. doi: 10.1038/s41598-018-20457-3.

    PubMed 29396481

  • Smoller JW, Gallagher PJ, Duncan LE, McGrath LM, Haddad SA, Holmes AJ, Wolf AB, Hilker S, Block SR, Weill S, Young S, Choi EY, Rosenbaum JF, Biederman J, Faraone SV, Roffman JL, Manfro GG, Blaya C, Hirshfeld-Becker DR, Stein MB, Van Ameringen M, Tolin DF, Otto MW, Pollack MH, Simon NM, Buckner RL, Ongur D, Cohen BM. The human ortholog of acid-sensing ion channel gene ASIC1a is associated with panic disorder and amygdala structure and function. Biol Psychiatry. 2014 Dec 1;76(11):902-10. doi: 10.1016/j.biopsych.2013.12.018. Epub 2014 Jan 18.

    PubMed 24529281

  • Battaglia M, Rossignol O, Bachand K, D'Amato FR, De Koninck Y. Amiloride modulation of carbon dioxide hypersensitivity and thermal nociceptive hypersensitivity induced by interference with early maternal environment. J Psychopharmacol. 2019 Jan;33(1):101-108. doi: 10.1177/0269881118784872. Epub 2018 Jul 3.

    PubMed 29968500

  • Chapman CD, Frey WH 2nd, Craft S, Danielyan L, Hallschmid M, Schioth HB, Benedict C. Intranasal treatment of central nervous system dysfunction in humans. Pharm Res. 2013 Oct;30(10):2475-84. doi: 10.1007/s11095-012-0915-1. Epub 2012 Nov 8.

    PubMed 23135822

  • Yellepeddi VK. Stability of extemporaneously prepared preservative-free prochlorperazine nasal spray. Am J Health Syst Pharm. 2018 Jan 1;75(1):e28-e35. doi: 10.2146/ajhp160531.

    PubMed 29273610

  • Knowles MR, Church NL, Waltner WE, Yankaskas JR, Gilligan P, King M, Edwards LJ, Helms RW, Boucher RC. Aerosolized amiloride as treatment of cystic fibrosis lung disease: a pilot study. Adv Exp Med Biol. 1991;290:119-28; discussion 129-32. doi: 10.1007/978-1-4684-5934-0_14. No abstract available.

    PubMed 1950741

  • Knowles MR, Church NL, Waltner WE, Yankaskas JR, Gilligan P, King M, Edwards LJ, Helms RW, Boucher RC. A pilot study of aerosolized amiloride for the treatment of lung disease in cystic fibrosis. N Engl J Med. 1990 Apr 26;322(17):1189-94. doi: 10.1056/NEJM199004263221704.

    PubMed 2157983

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Amiloride in people with Pharmacokinetics, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

amiloride plasma concentration (time frame: 10 minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04181008, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.

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