DOUBLE-BLIND PLACEBO-CONTROLLED RISING DOSE TOXICITY AND ACCEPTABILITY STUDY OF WR-5677 IN HEALTHY ADULT MALE VOLUNTEERS.
Rept. no. 3,
OKLAHOMA UNIV MEDICAL CENTER OKLAHOMA CITY EXPERIMENTAL THERAPEUTICS UNIT
Pagination or Media Count:
Sixty healthy adult male volunteers were divided into ten groups of 6 each of whom half received WR-5677 and half its matching placebo in double-blind fashion according to a pre-arranged randomized code. Daily doses of WR-5677 ranged from 6.6 mg for the first group to 390.3 mg for the final group, given in each instance in three equal doses for 3 consecutive days. Nausea and vomiting occurred in almost 23 of the subjects who received daily doses of WR-5677 of 111.6 or greater. All three subjects given the highest dose level of WR-5677 had mild reductions in hematocrit values suggesting the possibility that WR-5677 at high doses may produce hematocrit drops by an as yet unidentified mechanism. Otherwise WR-5677 appeared to be non-toxic and well-accepted warranting further clinical trials as an anti-malarial agent. Author