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news.DOV Pharmaceutical has commenced dosing in a second phase Ib clinical trial of its novel antidepressant, DOV 21,947. The trial is designed to determine the likely upper limit dose to be used in a phase II evaluation of efficacy and safety.
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A prior phase Ib study in normal volunteers conducted by DOV evaluated the safety and pharmacokinetics of repeat doses of DOV 21,947. That trial indicated the drug was well-tolerated and no dose-limiting side effects were seen.
The 28 subjects in the present trial will receive single or multiple doses of DOV 21,947 or placebo for one week. Safety is being measured by adverse reaction occurrences, vital signs, ECGs, clinical lab tests and other measures.
DOV expects to complete dosing by the end of the first quarter of 2006 and anticipates reporting the results in the second quarter of 2006, with the phase II efficacy trial planned to begin in the third quarter of 2006.