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PII-35Targeting nicotinic ligands in tobacco smoke by bioaffinity chromatography by A MACIUK; R MOADDEL; I WAINER is a Medicine article available to read on EtoBox.

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BACKGROUND/AIMS: Lecozotan is a new potent and silent 5-HT 1A antagonist being developed for the treatment of cognitive deficits associated with Alzheimer's disease. Pharmacokinetics (PK) and brain receptor occupancy data currently justify a twice-daily dosing regimen with the immediate release (IR) formulation and there is a need to develop a modified release formulation to allow oncedaily dosing of Lecozotan. The objective of this study was to assess the relative bioavailability of 3 new sustained/modified release (SR) formulations compared to the IR formulation. METHODS: This was a single-dose, randomized, 4-period, crossover study in 20 subjects who received 5 mg of all 4 (1 IR and 3 SR) formulations. Lecozotan PK parameters were compared between the 4 formulations using statistical analyses. RESULTS: Based on AUC 0-ρ , the SR-fast and SR-medium formulations were bioequivalent to the IR formulation. C max with the SR-fast and SR-medium formulations was ϳ 1/3 rd that of the IR formulation. C max /C 24h ratios for the SR-fast and SR-medium formulations were 2.8 and 2.3, respectively, in comparison to 23 for the IR formulation. Treatment-emergent adverse events were substantially

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Author

A MACIUK; R MOADDEL; I WAINER

Publisher

Nature Publishing Group; Wiley (Blackwell Publishing); Wiley-Blackwell; Wiley; Springer Science and Business Media LLC; Research Square (ISSN 0009-9236)

Published

2006

Language

EN

Field

Medicine (Health Sciences)