CS-8958 Clinical Pharmacology study - Safety and pharmacokinetics of nebulized laninamivir octanoate (CS-8958) after a single inhaled administration in healthy male Japanese subjects

After a single inhaled administration of CS-8958 40 to 320 mg, plasma concentrations of CS-8958 and laninamivir increased almost dose proportionally. After a single inhaled administration of CS-8958 160 mg, laninamivir was retained in the trachea and lungs over long periods, and these PK profiles support its long-lasting effect against influenza virus infection. A single administration of 40 to 320 mg of CS-8958 inhaled using a nebulizer was no safety concern and well tolerated in healthy adult subjects