Clinical trial NCT05962645 - References

Healthy — Phase 1 Study Into Pharmacokinetics and Food Effect of Vapendavir in Healthy Participants and Participants With COPD

Citation(s)

•   Abzug MJ, Michaels MG, Wald E, Jacobs RF, Romero JR, Sanchez PJ, Wilson G, Krogstad P, Storch GA, Lawrence R, Shelton M, Palmer A, Robinson J, Dennehy P, Sood SK, Cloud G, Jester P, Acosta EP, Whitley R, Kimberlin D; National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group
  A Randomized, Double-Blind, Placebo-Controlled Trial of Pleconaril for the Treatment of Neonates With Enterovirus Sepsis. J Pediatric Infect Dis Soc. 2016 Mar;5(1):53-62. doi: 10.1093/jpids/piv015. Epub 2015 Apr 16.
•   Altesa Biosciences Inc
  Investigator's Brochure for Vapendavir v 10. 2023
•   Barnard DL, Hubbard VD, Smee DF, Sidwell RW, Watson KG, Tucker SP, Reece PA
  In vitro activity of expanded-spectrum pyridazinyl oxime ethers related to pirodavir: novel capsid-binding inhibitors with potent antipicornavirus activity. Antimicrob Agents Chemother. 2004 May;48(5):1766-72. doi: 10.1128/AAC.48.5.1766-1772.2004.
•   Halpin DMG, Criner GJ, Papi A, Singh D, Anzueto A, Martinez FJ, Agusti AA, Vogelmeier CF
  Global Initiative for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease. The 2020 GOLD Science Committee Report on COVID-19 and Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2021 Jan 1;203(1):24-36. doi: 10.1164/rccm.202009-3533SO.
•   Hayden FG
  Rhinovirus and the lower respiratory tract. Rev Med Virol. 2004 Jan-Feb;14(1):17-31. doi: 10.1002/rmv.406.
•   Kaiser L, Crump CE, Hayden FG
  In vitro activity of pleconaril and AG7088 against selected serotypes and clinical isolates of human rhinoviruses. Antiviral Res. 2000 Sep;47(3):215-20. doi: 10.1016/s0166-3542(00)00106-6.
•   Mallia P, Message SD, Kebadze T, Parker HL, Kon OM, Johnston SL
  An experimental model of rhinovirus induced chronic obstructive pulmonary disease exacerbations: a pilot study. Respir Res. 2006 Sep 6;7(1):116. doi: 10.1186/1465-9921-7-116.
•   Message SD, Laza-Stanca V, Mallia P, Parker HL, Zhu J, Kebadze T, Contoli M, Sanderson G, Kon OM, Papi A, Jeffery PK, Stanciu LA, Johnston SL
  Rhinovirus-induced lower respiratory illness is increased in asthma and related to virus load and Th1/2 cytokine and IL-10 production. Proc Natl Acad Sci U S A. 2008 Sep 9;105(36):13562-7. doi: 10.1073/pnas.0804181105. Epub 2008 Sep 3.
•   Newcomb DC, Peebles RS Jr
  Bugs and asthma: a different disease? Proc Am Thorac Soc. 2009 May 1;6(3):266-71. doi: 10.1513/pats.200806-056RM.
•   Proud D
  Host response to human rhinovirus infection: toward targeted treatment strategies. Future Virology 2009; 4: 97-10
•   Sykes A, Johnston SL
  Etiology of asthma exacerbations. J Allergy Clin Immunol. 2008 Oct;122(4):685-688. doi: 10.1016/j.jaci.2008.08.017.
•   US Food and Drug Administration Center for Drug Evaluation and Research
  Draft Guidance: Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations Guidance for Industry. 2019.
•   Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R
  Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
•   Wheaton AG, Cunningham TJ, Ford ES, Croft JB; Centers for Disease Control and Prevention (CDC)
  Employment and activity limitations among adults with chronic obstructive pulmonary disease--United States, 2013. MMWR Morb Mortal Wkly Rep. 2015 Mar 27;64(11):289-95.
•   Zafari Z, Li S, Eakin MN, Bellanger M, Reed RM
  Projecting Long-term Health and Economic Burden of COPD in the United States. Chest. 2021 Apr;159(4):1400-1410. doi: 10.1016/j.chest.2020.09.255. Epub 2020 Oct 2.

A Phase 1 Study to Confirm the Single- and Multiple-dose Pharmacokinetics and to Evaluate Food Effect of Vapendavir in Healthy Participants and Participants With COPD

Details for clinical trial NCT05962645