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PHARMACOKINETICS

Tolerability, Pharmacokinetics, and Neuroendocrine Effects of PRX-00023, a Novel 5-HT1A Agonist, in Healthy Subjects

Ganesh R. Iyer, PhD, John F. Reinhard, Jr, PhD, Scott Oshana, Michael Kauffman, MD, PhD and Stephen Donahue, MD

From Epix Pharmaceuticals, Lexington, MA.

PRX-00023 is a novel, nonazapirone 5-HT1A agonist in clinical development for treatment of affective disorders. The objectives of the initial clinical phase I studies (a single ascending dose study and multiple dose-ascending and high-dose titration studies) were to measure the pharmacokinetics, pharmacodynamic (neuroendocrine) effects, and tolerability of PRX-00023 in healthy subjects. The studies evaluated 10-mg to 150-mg doses of PRX-00023 in up to 112 healthy male and female subjects aged 18 to 54 years. Single and multiple oral doses of PRX-00023 were found to be safe and well tolerated in healthy subjects. PRX-00023 was absorbed relatively rapidly, with a tmax of 0.5 to 2 hours, and eliminated with a half-life of approximately 12 hours. PRX-00023 treatment transiently increased blood prolactin levels 2 to 3 hours after administration, consistent with its mechanism as a 5-HT1A agonist.

Key Words: PRX-00023 • serotonin • 5-HT1A • affective disorders • pharmacokinetics (PK) and pharmacodynamics (PD) • phase I

Address for correspondence: Ganesh R. Iyer, Epix Pharmaceuticals, 4 Maguire Road, Lexington, MA 02421; e-mail: giyer{at}epixpharma.com.






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