J Clin Pharmacol
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First published on May 1, 2007, doi:10.1177/0091270007299431

The Journal of Clinical Pharmacology 2007;47:704.

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©© 2007 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology , 10.1177/0091270007299431

Article

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

Kimberly E. Vanover 1*, Doris Robbins-Weilert 2, Darren G. Wilbraham 3, Timothy G. K. Mant 3, Daniel P. van Kammen 1, Robert E. Davis 1, and David M. Weiner 1

1 ACADIA Pharmaceuticals Inc, San Diego, California
2 Quintiles, Inc, Kansas City, Missouri
3 GDRU Quintiles, Limited, London, United Kingdom

* To whom correspondence should be addressed. E-mail: kvanover{at}intracellulartherapies.com.


  Abstract
The pharmacokinetics, safety, and tolerability of ACP-103, a selective serotonin 5-HT2A 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 Cmax values (9-152 ng/mL) and AUC0-{infty} (706-10 798 h·ng/mL), and multiple doses (50-150 mg) resulted in dose-proportionate mean Cmax,ss (93-248 ng/mL) and AUC0-{infty},ss (1839-4680 h·ng/mL). The half-life of ACP-103 was approximately 55 hours, with a tmax 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.
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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.
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