Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers

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.

Timeline

Start

2020-09-28

Primary completion

2022-08-30

Completion

2023-03-06

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background Noone PG, Regnis JA, Liu X, Brouwer KL, Robinson M, Edwards L, Knowles MR. Airway deposition and clearance and systemic pharmacokinetics of amiloride following aerosolization with an ultrasonic nebulizer to normal airways. Chest. 1997 Nov 5;112(5):1283-90. doi: 10.1378/chest.112.5.1283.
• Background Olivier KN, Bennett WD, Hohneker KW, Zeman KL, Edwards LJ, Boucher RC, Knowles MR. Acute safety and effects on mucociliary clearance of aerosolized uridine 5'-triphosphate +/- amiloride in normal human adults. Am J Respir Crit Care Med. 1996 Jul;154(1):217-23. doi: 10.1164/ajrccm.154.1.8680683.
• Background Sood N, Bennett WD, Zeman K, Brown J, Foy C, Boucher RC, Knowles MR. Increasing concentration of inhaled saline with or without amiloride: effect on mucociliary clearance in normal subjects. Am J Respir Crit Care Med. 2003 Jan 15;167(2):158-63. doi: 10.1164/rccm.200204-293OC. Epub 2002 Oct 31.

Drugs

Indications

No indication recorded.