Safety, Tolerability, and Pharmacokinetics of the Novel Anti-influenza Agent Baloxavir Marboxil in Healthy Adults: Phase I Study Findings

Clinical Drug Investigation

Volumn 38, Issue 12, 2018, Pages 1189-1196

  Koshimichi, Hiroki ^a   Ishibashi, Toru ^a   Kawaguchi, Nao ^a   Sato, Chisako ^a   Kawasaki, Akira ^a   Wajima, Toshihiro ^a  

^a SHIONOGI AND CO LTD   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BALOXAVIR MARBOXIL; LACTATE DEHYDROGENASE; PLACEBO; ANTIVIRUS AGENT; BALOXAVIR; OXAZINE DERIVATIVE; PRODRUG; PYRIDINE DERIVATIVE; THIEPIN DERIVATIVE; TRIAZINE DERIVATIVE;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG SAFETY; DRUG TOLERABILITY; ELIMINATION HALF-LIFE; EOSINOPHIL COUNT; FASTING; FOOD; FOOD DRUG INTERACTION; HEADACHE; HUMAN; HUMAN EXPERIMENT; JAPANESE (PEOPLE); LACTATE DEHYDROGENASE BLOOD LEVEL; LEUKOCYTE COUNT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PHARMACOKINETIC PARAMETERS; PRIORITY JOURNAL; SIDE EFFECT; SINGLE DRUG DOSE; STOMATITIS; URINARY EXCRETION; YOUNG ADULT; BLOOD; CHEMICALLY INDUCED; CLINICAL TRIAL; CROSSOVER PROCEDURE; DIET RESTRICTION; DOUBLE BLIND PROCEDURE; FOLLOW UP; INFLUENZA; MIDDLE AGED; PHASE 1 CLINICAL TRIAL; PHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL;

ADULT; ANTIVIRAL AGENTS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; FASTING; FOLLOW-UP STUDIES; FOOD-DRUG INTERACTIONS; HEADACHE; HEALTHY VOLUNTEERS; HUMANS; INFLUENZA, HUMAN; MALE; MIDDLE AGED; OXAZINES; PRODRUGS; PYRIDINES; THIEPINS; TRIAZINES;

EID: 85054580352     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.1007/s40261-018-0710-9     Document Type: Article

References (12)

1. Paules C, Subbarao K. Influenza. Lancet. 2017;390:697–708
2. Iuliano AD, Roguski KM, Chang HH, Global Seasonal Influenza-associated Mortality Collaborator Network, et al. Estimates of global seasonal influenza-associated respiratory mortality: a modelling study. Lancet. 2018;391(10127):1285–300
3. World Health Organization. WHO fact sheet: influenza (seasonal). 2018. http://www.who.int/mediacentre/factsheets/fs211/en/. Accessed Mar 2018
4. Ison MG. Antiviral treatments. Clin Chest Med. 2017;38:139–53
5. Treanor JJ, Hayden FG, Vrooman PS, et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial.US Oral Neuraminidase Study Group. JAMA. 2000;283:1016–24
6. Lee N, Hui DS, Zuo Z, et al. A prospective intervention study on higher-dose oseltamivir treatment in adults hospitalized with influenza A and B infections. Clin Infect Dis. 2013;57:1511–9
7. Kondo H, Shobugawa Y, Hibino A, et al. Influenza virus shedding in laninamivir-treated children upon returning to school. Tohoku J Exp Med. 2016;238:113–21
8. Zhang F, Bi Y, Wang J, et al. Human infections with recently-emerging highly pathogenic H7N9 avian influenza virus in China. J Infect. 2017;75:71–5
9. Takashita E, Ejima M, Ogawa R, et al. Antiviral susceptibility of influenza viruses isolated from patients pre- and post-administration of favipiravir. Antiviral Res. 2016;132:170–7
10. Food and Drug Administration Center for Drug Evaluation and Research. Guidance for industry: food-effect bioavailability and fed bioequivalence studies. 2002. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070241.pdf. Accessed Mar 2018
11. Noshi T, Satou K, Ishibashi T, et al. Pharmacokinetic and pharmacodynamic analysis of S-033188/S-033447, a novel inhibitor of influenza virus Cap-dependent endonuclease, in mice infected with influenza A virus [abstract]. In: 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID); 22–25 April 2017: Vienna
12. Omoto S, Speranzini V, Hashimoto T, et al. Characterization of influenza virus variants induced by treatment with the endonuclease inhibitor baloxavir marboxil. Sci Rep. 2018;8:article number 9633