Army Drug Development Program. Phase I. Clinical Testing.
Annual rept. Feb 81-Feb 82,
BIO-MED INC COLLEGE PARK MD
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In a double-blind study of safety and tolerance, 32 healthy male subjects were each given from 750 to 1500 mg of the drug WR 180,409 H3PO4, or placebo, in 3 doses over a period of 24 hours. Blood specimens were collected at the designated times and sent to the Department of Pharmacology, Walter Reed Army Institute of Research, for determination of the pharmacokinetics of WR 180,409 H3 PO4 in multiple doses. Although mild gastrointestinal symptons or lightheadedness were observed in one of every four subjects receiving the drug, there was no apparent doseresponse relationship and equivalent symptons were also encountered in subjects receiving placebo. No clear-cut signs of intolerance were noted at any dose level administered.