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Pharmacyclics, Inc. (PCYC) has completed a Phase 1 clinical trial with PCI-27483, the company's novel, first-in-class small-molecule Factor VIIa inhibitor. The trial was conducted in sixteen healthy volunteers to evaluate the safety and pharmacologic effect of PCI-27483. A single administration of PCI-27483 resulted in a linear dose response in the International Normalized Ratio (INR), a routine laboratory test used to assess the level of anticoagulation (blood-thinning).
In the study, PCI-27483 increased the INR with minimal intra-subject variation and a half-life of ten hours. At the highest subcutaneous dose of PCI-27483 evaluated, a mean (+/-standard error) peak INR of 2.72 (+/- 0.24) was achieved one to two hours post-dosing. The trial further established doses of PCI-27483, which upon repeated dosing are expected to maintain the INR in the range of 2.0 to 3.0, the target window for treatment and prevention of thromboembolic events (i.e., formation of blood clots).
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