Gliatech Histamine Antagonist Shows Positive Phase I Results Dow Jones Newswires -- March 1, 1999
CLEVELAND --Gliatech said data from a Phase I rising single- dose clinical study of its GT2331 histamine H3 antagonist, for the potential treatment of Alzheimer's, Attention Deficit Hyperactivity Disorder and sleep disorders, demonstrated positive results.
In a press release Monday, the therapeutic products maker said the Phase I study of GT2331 was a double-blind, randomized, placebo-controlled trial designed to investigate the safety, tolerability and pharmacokinetic profile of GT2331 in healthy volunteers.
Gliatech said several doses of GT2331 or placebo were administered, and said no serious adverse events occurred at the doses evaluated, with no clinically significant blood chemistry or hematological differences in treated and controlled patients.
The company said pharmacokinetic analysis indicated GT2331 blood levels higher than those expected for pharmacological effect, and said GT2331 exhibited a plasma half-life which should allow for once-daily dosing.
Gliatech said based on the favorable Phase I results, the company initiated a rising multiple dose study, in which several doses of GT2331 will be administered for two weeks to healthy volunteers.
(Richard H - So far so good!) Peter
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