NDLI: 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.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Ishizuka, Hitoshi Yoshiba, Satoshi Okabe, Hiromi Yoshihara, Kazutaka
Description	Country affiliation: Japan Author Affiliation: Ishizuka H ( Translational Medicine and Clinical Pharmacology Department, Daiichi Sankyo Co, Ltd, 1-2-58, Hiromachi, Shinagawa, Tokyo 140-8710, Japan. ishizuka.hitoshi.h8@daiichisankyo.co.jp)
Abstract	Phase 1 studies of laninamivir, a novel long-acting neuraminidase inhibitor, were carried out to assess its safety, tolerability, and pharmacokinetics after inhaled administration of its prodrug, CS-8958. Healthy male volunteers (total N = 76) participated in double-blind, randomized, placebo-controlled trials and received 5, 10, 20, 40, 80, or 120 mg of a single dose or 20 or 40 mg of a twice-daily dose for 3 days. The clinical and laboratory parameters and plasma and urinary concentrations of CS-8958 and laninamivir for 144 hours post dosing were measured. There were no adverse events related to the test drug. CS-8958 disappeared from plasma with a half-life of about 2 hours, although laninamivir was slowly eliminated from the body, lasting for even up to 144 hours after administration with a half-life of about 3 days. Area under the curve and maximum concentration increased almost linearly with the dose administered. The cumulative urinary excretion amounts of CS-8958 and laninamivir were 2.3% to 3.6% and 10.7% to 14.6% of the dose, respectively. The half-life of the urinary excretion rates of laninamivir at higher single dose is comparable to plasma half-life. CS-8958, when inhaled by healthy volunteers, is well tolerated and exhibits a suitable pharmacokinetic profile, suggesting potential for long-lasting anti-influenza activity.
File Format	HTM / HTML
ISSN	00912700
Issue Number	11
Volume Number	50
e-ISSN	15524604
Journal	The Journal of Clinical Pharmacology
Language	English
Publisher	Wiley
Publisher Date	2010-11-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Enzyme Inhibitors Pharmacokinetics Zanamivir Analogs & Derivatives Administration, Inhalation Adult Area Under Curve Dose-response Relationship, Drug Double-blind Method Drug Administration Schedule Adverse Effects Half-life Humans Male Middle Aged Neuraminidase Antagonists & Inhibitors Prodrugs Young Adult Administration & Dosage Clinical Trial, Phase I Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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