J Clin Pharmacol
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First published on March 20, 2009, doi:10.1177/0091270009333488

The Journal of Clinical Pharmacology 2009;49:606.

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©© 2009 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology, 10.1177/0091270009333488

Article

An Oral Human Drug Absorption Study to Assess the Impact of Site of Delivery on the Bioavailability of Bevirimat

Alyson Connor 1, Phil Evans 1, Judy Doto 2, Corey Ellis 2, and David E. Martin 2*

1 Pharmaceutical Profiles Ltd
2 Panacos Pharmaceuticals, Inc

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


  Abstract
Bevirimat is a first in class, orally active, potent and selective inhibitor of HIV-1. It may have utility for the treatment of HIV-1-infected patients who are failing current regimens because of the development of drug resistance. In earlier studies in HIV-1-infected patients, an immediate-release tablet formulation exhibited a relative bioavailability (Frel) of 50% or greater and a higher intersubject variability than an oral solution. The purpose of this study was to determine whether this pharmacokinetic profile is attributable to a narrow permeability-dependent absorption window within the gastrointestinal tract. Three groups of subjects completed an open-label, 2-way crossover, randomized pharmacoscintigraphic study. Subjects received a 25-mg bevirimat oral immediate-release solution plus 25 mg bevirimat solution delivered to the proximal small bowel, distal small bowel, or colon via the EnterionTM capsule. The results indicate that the permeability of bevirimat throughout the small intestine was excellent and suggest that the variability observed for the immediate release tablet was not related to the presence of an absorption window in the small intestine.
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