Phase I study of micafungin

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  • Micafunginの第I相試験

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Abstract

The safety and pharmacokinetics of micafungin (MCFG) were examined using 36 healthy male volunteers both in single and repeated administration studies. In the single administration study, 2.5, 5, 12.5, 25 and 50mg of MCFG were given intravenously with continuous infusion pump over a 2-hour period. In the repeated administration study, 25mg of MCFG or placebo was given intravenously once daily for seven days with continuous infusion pump over a 1-hour period. The results were as follows:<BR>1) MCFG was well tolerated with no drug-related adverse events observed.<BR>2) Mean plasma concentrations of unchanged drug reached maximum at the end of administration, and declined in a bi-exponential manner afterwards.<BR>3) There were no differences among dose groups in elimination rate constant (β), elimination halflife (t1/2), volume of distribution at steady state (Vdss) and total clearance (CLt). Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) and maximum plasma concentration (Cmax) increased in proportion to the dose. Consequently, the pharmacokinetics of MCFG were considered to be linear over the dose range studied.<BR>4) The plasma concentrations of unchanged drug reached a steady state by day 4 in the repeated administration study with no accumulation observed.<BR>5) The metabolites M 1 (catechol form) and M 2 (methoxy form), that are found in rats and dogs, were hardly detected. Urinary excretion was extremely low for the unchanged drug, and for metabolites M 1 and M2.

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