Assessment of the effects of renal impairment on the pharmacokinetic profile of laninamivir, a novel neuraminidase inhibitor, after a single inhaled dose of its prodrug, CS-8958

Journal of Clinical Pharmacology

Volumn 51, Issue 2, 2011, Pages 243-251

  Ishizuka, Hitoshi ^a   Yoshiba, Satoshi ^a   Yoshihara, Kazutaka ^a   Okabe, Hiromi ^a  

^a DAIICHI SANKYO CO   (Japan)

Author keywords

CS 8958; Laninamivir; neuraminidase inhibitor; pharmacokinetics; R 125489; renal

Indexed keywords

LANINAMIVIR; LANINAMIVIR OCTANOATE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; CREATININE CLEARANCE; DRUG EFFECT; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; FEMALE; HUMAN; KIDNEY CLEARANCE; KIDNEY DYSFUNCTION; KIDNEY FAILURE; LIQUID CHROMATOGRAPHY; MALE; MAXIMUM PLASMA CONCENTRATION; OPEN STUDY; SINGLE DRUG DOSE; TANDEM MASS SPECTROMETRY; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADMINISTRATION, INHALATION; AGED; AGED, 80 AND OVER; AREA UNDER CURVE; ENZYME INHIBITORS; FEMALE; HALF-LIFE; HUMANS; MALE; MIDDLE AGED; NEURAMINIDASE; PRODRUGS; RENAL INSUFFICIENCY; SEVERITY OF ILLNESS INDEX; ZANAMIVIR;

EID: 79551709651     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010361914     Document Type: Article

References (15)

1. Hayden F. Developing new antiviral agents for influenza treatment: what dose the future hold? Clin Infect Dis. 2009 ; 48: S3 - S13.
2. Hayden F., Osterhaus A., Treanor JJ, et al. Efficacy and safety of the neuraminidase inhibitor zanamivir in the treatment of influenzavirus infections. N Engl J Med. 1997 ; 337: 874-880.
3. Honda T., Masuda T., Yoshida S., et al. Synthesis and anti-influenza virus activity of 4-guanidino-7-substituted neu5ac2en derivatives. Bioorg Med Chem Lett. 2002 ; 12: 1921-1924. (Pubitemid 34756449)
4. Yamashita M., Tomozawa T., Kakuta M., et al. CS-8958, a prodrug of the new neuraminidase inhibitor R-125489, shows long-acting anti-influenza virus activity. Antimicrob Agents Chemother. 2009 ; 53: 186-192.
5. Itoh Y., Shinya K., Kiso M., et al. In vitro and in vivo characterization of new swine-origin H1N1 influenza viruses. Nature 2009: 460 ; 1021-1027.
6. Honda T., Kubo S., Masuda T., et al. Synthesis and in vivo influenza virus-inhibitory effect of ester prodrug of 4-guanidino-7-O-methyl-neu5ac2en. Bioorg Med Chem Lett. 2009 ; 19: 2938-2940.
7. Neumann G., Noda T., Kawaoka Y. Emergence and pandemic potential of swine-origin H1N1 influenza virus. Nature. 2009 ; 459: 931-939.
8. Koyama K., Takahashi M., Oitate M., et al. CS-8958, a prodrug of the novel neuraminidase inhibitor R-125489, demonstrates a favorable, long retention profile in the mouse respiratory tract. Antimicrob Agents Chemother. 2009 ; 53: 4845-4851.
9. Koyama K., Takahashi M., Oitate M., et al. Pharmacokinetics and disposition of CS-8958, a long-acting prodrug of the novel neuraminidase inhibitor laninamivir in rats. Xenobiotica. 2010 ; 40: 207-216.
10. Ishizuka H., Yoshiba S., Okabe H., et al. Clinical pharmacokinetics of laninamivir, a novel long-acting neuraminidase inhibitor, after single and multiple inhaled doses of its prodrug, CS-8958, in healthy male volunteers. J Clin Pharmacol. 2009 ; doi: 10.1177/ 0091270009356297.
11. Brater DC Drug dosing in patients with impaired renal function. Clin Pharmacol Ther. 2009 ; 86: 483-489.
12. Nolin D., Naud J., Leblond A., et al. Emerging evidence of the impact of kidney disease on drug metabolism and transport. Clin Pharmacol Ther. 2008 ; 83: 898-903.
13. Zhang Y., Zang L., Abraham S., et al. Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications. Clin Pharmacol Ther. 2009 ; 85: 305-311.
14. Dreisbach AW The influence of chronic renal failure on drug metabolism and transport. Clin Pharmacol Ther. 2009 ; 86: 553-556.
15. FDA guidance for industry. Pharmacokinetics in patients with impaired renal function-study design, data analysis, and impact on dosing and labeling ; 1998. http://www.fda.gov/cder/guidance/1449fnl.pdf