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Home > Scientific articles
Sep 2024

Bioavailability of a novel sustained-release pellet formulation of 5-flucytosine in healthy-fed participants for use in patients with cryptococcal meningitis

Clinical and Translational Science

by Zekri Lassout NI, Goyal V, Krantz E, Simon F, Neven A, Eriksson J, Saayman A, Satam V, Ruffell C, Victor S, Chenel M, Celebic A, Caplain H,  Gillon J-Y, Deshmukh A, Antarkar A, Sjögren E, Ribeiro I. Clinical and Translational Science 2024, 17(9): e13908. doi: 10.1111/cts.13908

Summary: 5-flucytosine, a treatment for cryptococcal meningoencephalitis, has a limited plasma half-life and must be administered every 6 hours. This poses major practical challenges that may result in treatment failure and death. The authors of this manuscript describe a phase I study in healthy, fed participants that assessed the safety and pharmacokinetic profiles of single-doses of a sustained-release formulation of 5-flucytosine and an immediate-release formulation of 5-flucytosine. The results of this study suggest that the sustained-release formulation of 5-flucytosine is a good candidate for further investigation in future studies in patients. Physiologically-based pharmacokinetic modeling predicts that a 6000 mg dose of this formulation, given twice a day in the fasted state, would be effective and safe.

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Translational research Cryptococcal meningitis

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