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The Effect of Ravuconazole on the Pharmacokinetics of Nelfinavir in Healthy Male Volunteers

From Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, New Jersey. Dr Kanamaluru is currently at Sanofi Aventis, Malvern, Pennsylvania.

An open-label, nonrandomized study was conducted to assess the effect of ravuconazole on the pharmacokinetics of concomitantly administered nelfinavir. Healthy volunteers received 750 mg nelfinavir on day 1, 750 mg nelfinavir and 400 mg ravuconazole on day 2, 400 mg ravuconazole on days 3 to 28, and 750 mg nelfinavir and 400 mg ravuconazole on day 29. The geometric means of C_max and area under the curve of nelfinavir coadministered with ravuconazole were 30.7% and 31.9% higher on day 2 and 7.9% and 16.2% lower on day 29, respectively, compared to the corresponding values on day 1. These findings are consistent with the potential for ravuconazole to both inhibit and induce CYP3A isozymes. The alterations in the systemic exposure to nelfinavir were within the range defined by the 90% confidence interval. The study data indicate that coadministration of ravuconazole did not result in a clinically significant change in the plasma levels of nelfinavir.

Key Words: Nelfinavir • ravuconazole • pharmacokinetics

Address for reprints: Jing-He Yan, PhD, Bristol-Myers Squibb, PO Box 4000, Princeton, NJ 08542-4000.

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