Arena Pharmaceuticals, Inc. ARNA announced today results from a Phase 1 clinical trial of APD811, an
orally bioavailable agonist of the prostacyclin receptor which is intended for
the treatment of pulmonary arterial hypertension, or PAH.
The randomized, double-blind and placebo-controlled trial evaluated the
safety, tolerability and pharmacokinetics of 0.03 mg, 0.05 mg, 0.1 mg and 0.2
mg single doses of APD811. The trial evaluated 32 healthy volunteers in four
cohorts of eight participants each – six randomized to APD811 and two to
placebo. APD811 was rapidly absorbed and demonstrated dose-proportional
pharmacokinetic exposure over the tested dose range. The terminal half-life
was approximately 20 hours.
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