Arena Pharmaceuticals, Inc. (ARNA) announced positive results from a multiple-ascending dose Phase 1b clinical trial of APD791 evaluating its safety, pharmacokinetics and pharmacodynamics. APD791 is Arena's internally discovered oral drug candidate intended for the treatment of arterial thrombosis and other related conditions.
Acording to the company, the Phase 1b trial was a randomized, double-blind, placebo-controlled, multiple-ascending dose trial in 50 healthy adult male and female volunteers. Daily doses ranged from 15 mg to 240 mg and were generally well tolerated.
In addition to evaluating APD791's safety and tolerability profile, the trial evaluated the pharmacokinetics and pharmacodynamics of multiple oral doses of APD791 over a period of one week. Arena Pharma said that APD791 was rapidly absorbed and exposures were related to dose. Dose-dependent inhibition of serotonin-mediated amplification of platelet aggregation was demonstrated starting at the 15 mg dose and will permit the identification of exposure ranges that produce minimal, moderate and near-complete inhibition of serotonin-mediated platelet aggregation.
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