J Clin Pharmacol
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CLINICAL STUDIES

Safety, Tolerability, and Exposure of Ciclesonide Nasal Spray in Healthy and Asymptomatic Subjects With Seasonal Allergic Rhinitis

Ruediger Nave, PhD, Mark A. Wingertzahn, PhD, Sheldon Brookman, PhD, Shigenori Kaida and Takashi Matsunaga, PhD

From ALTANA Pharma AG, Konstanz, Germany (Dr Nave), ALTANA Pharma, Florham Park, New Jersey (Dr Wingertzahn), Teijin America Inc, Princeton, New Jersey (Dr Brookman), and Teijin Pharma Limited, Tokyo, Japan (Mr Kaida, Dr Matsunaga).

Ciclesonide is an intranasal corticosteroid in development for the treatment of allergic rhinitis. To assess the safety, tolerability, and pharmacokinetics of ciclesonide, adult healthy volunteers and asymptomatic subjects with seasonal allergic rhinitis were randomized to receive intranasal ciclesonide or placebo for 14 days. Serum concentrations of ciclesonide and its active metabolite, desisobutyryl-ciclesonide, were measured using high-performance liquid chromatography assay with tandem mass spectrometric detection, with lower limits of quantification of 25 and 10 pg/mL, respectively. Adrenal function was monitored by diurnal serum free and 24-hour urine cortisol concentrations. Despite the use of a sensitive assay and a high ciclesonide dose (800 µg/d), serum levels of ciclesonide and desisobutyryl-ciclesonide were below the lower limits of quantification for the majority of samples assayed. Ciclesonide was well tolerated and did not appear to affect serum or urine free cortisol levels. The low systemic exposure and favorable safety profile support the continued clinical development of ciclesonide nasal spray.

Key Words: Intranasal corticosteroid • nasal allergies • systemic bioavailability • cortisol • adrenal function

Address for reprints: Ruediger Nave, PhD, Altana Pharma AG, Byk-Gulden-Str. 2, 78467 Konstanz, Germany.


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