Multiple-dose pharmacokinetics, pharmacodynamics, and safety of taranabant, a novel selective cannabinoid-1 receptor inverse agonist, in healthy male volunteers

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Abstract

Taranabant is a cannabinoid-1 receptor inverse agonist for the treatment of obesity. This study evaluated the safety, pharmacokinetics, and pharmacodynamics of taranabant (5, 7.5, 10, or 25 mg once daily for 14 days) in 60 healthy male subjects. Taranabant was rapidly absorbed, with a median t max of 1.0 to 2.0 hours and a t1/2 of approximately 74 to 104 hours. Moderate accumulation was observed in Cmax (1.18- to 1.40-fold) and AUC0-24 h (1.5- to 1.8-fold) over 14 days for the 5-, 7.5-, and 10-mg doses, with an accumulation half-life ranging from 15 to 21 hours. Steady state was reached after 13 days. After multiple-dose administration, plasma AUC0-24 h and Cmax of taranabant increased dose proportionally (5-10 mg) and increased somewhat less than dose proportionally for 25 mg. Taranabant was generally well tolerated up to doses of 10 mg and exhibited multiple-dose pharmacokinetics consistent with once-daily dosing. © 2008 the American College of Clinical Pharmacology.

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APA

Addy, C., Rothenberg, P., Li, S., Majumdar, A., Agrawal, N., Li, H., … Wagner, J. (2008). Multiple-dose pharmacokinetics, pharmacodynamics, and safety of taranabant, a novel selective cannabinoid-1 receptor inverse agonist, in healthy male volunteers. Journal of Clinical Pharmacology, 48(6), 734–744. https://doi.org/10.1177/0091270008317591

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