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.
journal_name
J Clin Pharmacoljournal_title
Journal of clinical pharmacologyauthors
Iyer GR,Reinhard JF Jr,Oshana S,Kauffman M,Donahue Sdoi
10.1177/0091270007300953subject
Has Abstractpub_date
2007-07-01 00:00:00pages
817-24issue
7eissn
0091-2700issn
1552-4604pii
0091270007300953journal_volume
47pub_type
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