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Concomitant Cyclosporine and Micafungin Pharmacokinetics in Healthy Volunteers

From the University of Washington, Department of Pharmacy, Seattle, Washington (Dr Hebert, Dr Blough); Fujisawa Healthcare Inc, Deerfield, Illinois (Dr Townsend, Dr Buell, Dr Keirns, Dr Bekersky); Covance, Madison, Wisconsin (Dr Austin, Dr Balan).

Cyclosporine is a marketed immunosuppressive agent and a known substrate for CYP3A. Micafungin is an antifungal agent and a mild inhibitor of CYP3A-mediated metabolism in vitro. The objectives of this study were to evaluate the pharmacokinetics of cyclosporine and micafungin before and with concomitant administration. The pharmacokinetics of single-dose oral cyclosporine (5 mg/kg) were estimated on days 1, 9, and 15 (n = 27). Subjects received micafungin (100 mg/d over 1 hour) on days 7, 9, and 11 through 15. Micafungin pharmacokinetics were estimated on days 7, 9, and 15. Mean apparent oral cyclosporine clearances were estimated to be 645±236 mL/h/kg, 546±101 mL/h/kg (P = .01), and 540±104 mL/h/kg (P = .02) for days 1, 9, and 15, respectively. Micafungin appears to be a mild inhibitor of cyclosporine metabolism.

Key Words: Cyclosporine • micafungin • pharmacokinetics • drug interaction

Address for reprints: Mary F. Hebert, PharmD, University of Washington, Department of Pharmacy, H-375 Health Sciences Center, Box 357630, Seattle, WA 98195-7630.

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