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Pharmacokinetics, Tolerability, and Safety of ACP-103 Following Single or Multiple Oral Dose Administration in Healthy Volunteers

From ACADIA Pharmaceuticals Inc, San Diego, California (Dr Vanover, Dr van Kammen, Dr Davis, Dr Weiner); Quintiles, Inc, Kansas City, Missouri (Dr Robbins-Weilert); and GDRU Quintiles, Limited, London, United Kingdom (Dr Wilbraham, Dr Mant).

The pharmacokinetics, safety, and tolerability of ACP-103, a selective serotonin 5-HT_2A receptor inverse agonist, were evaluated in 2 double-blind, placebo-controlled, dose escalation studies in healthy male volunteers. Pharmacokinetic sampling was measured up to 216 hours after single oral/nasogastric doses of ACP-103 and after the last dose of once-daily oral administration of ACP-103 for 14 days. Single doses of ACP-103 (20-300 mg) resulted in dose-proportionate mean C_max values (9-152 ng/mL) and AUC_0- (706-10 798 h·ng/mL), and multiple doses (50-150 mg) resulted in dose-proportionate mean C_max,ss (93-248 ng/mL) and AUC_0-,ss (1839-4680 h·ng/mL). The half-life of ACP-103 was approximately 55 hours, with a t_max at 6 hours. ACP-103 was well tolerated at single doses up to and including 300 mg and multiple doses up to 100 mg once daily for 14 days.

Key Words: Antipsychotic • phase I • serotonin • 5-HT_2A • inverse agonist

Address for reprints: Kimberly E. Vanover, PhD, current address, Intra-Cellular Therapies, Inc, 3960 Broadway, New York, NY 10032; e-mail: kvanover{at}intracellulartherapies.com.

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				K. E. Vanover, D. Robbins-Weilert, D. G. Wilbraham, T. G. K. Mant, D. P. van Kammen, R. E. Davis, and D. M. Weiner The Effects of Food on the Pharmacokinetics of a Formulated ACP-103 Tablet in Healthy Volunteers J. Clin. Pharmacol., July 1, 2007; 47(7): 915 - 919. [Full Text] [PDF]