Accession Number : AD0692311

Title :   DOUBLE-BLIND PLACEBO-CONTROLLED RISING DOSE TOXICITY AND ACCEPTABILITY STUDY OF WR-5677 IN HEALTHY ADULT MALE VOLUNTEERS.

Descriptive Note : Rept. no. 3,

Corporate Author : OKLAHOMA UNIV MEDICAL CENTER OKLAHOMA CITY EXPERIMENTAL THERAPEUTICS UNIT

Personal Author(s) : Colmore,John P. ; Desper,Paul C. ; Kyriakopoulos,A. A. ; Vloedman,D. A.

Report Date : 29 APR 1969

Pagination or Media Count : 385

Abstract : 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 2/3 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)

Descriptors :   (*ANTIMALARIALS, TOXICITY), DISEASES, TOXIC TOLERANCES, DOSAGE, HEMATOLOGY, PATHOLOGY, BLOOD CHEMISTRY, HUMANS

Subject Categories : Toxicology
      Pharmacology

Distribution Statement : APPROVED FOR PUBLIC RELEASE