Tolerability, pharmacokinetics, and neuroendocrine effects of PRX-00023, a novel 5-HT1A agonist, in healthy subjects.

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Iyer GR, Reinhard JF Jr, Oshana S, Kauffman M, Donahue S

Tolerability, pharmacokinetics, and neuroendocrine effects of PRX-00023, a novel 5-HT1A agonist, in healthy subjects.

J Clin Pharmacol. 2007 Jul;47(7):817-24. doi: 10.1177/0091270007300953. Epub 2007 May 10.

PubMed ID

17495280 [ View in PubMed

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Abstract

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.

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Drug Targets

Drug	Target	Kind	Organism	Pharmacological Action	Actions
Naluzotan	5-hydroxytryptamine receptor 1A	Protein	Humans	Unknown	Agonist	Details