Accession Number : AD0758432

Title :   Acute Tolerance Study of WR-2721. Volume I. A Double Blind Comparison of Placebo and WR-2721 in Normal Adult Volunteers,

Corporate Author : OKLAHOMA UNIV HEALTH SCIENCES CENTER OKLAHOMA CITY MCALESTER DIV OF CLINICAL PHARMACOLOGY

Personal Author(s) : Czerwinski,Anthony W. ; Czerwinski,Anthony B. ; Clark,Mervin L. ; Whitsett,Thomas L.

Report Date : 14 DEC 1972

Pagination or Media Count : 164

Abstract : WR-2721 is a compound having anti-radiation activity in experimental animals. This study was designed to assess the safety of oral doses of WR-2721 in normal adult volunteers. The doses tested ranged from 100 to 5,000 mg over a single day. The subjects were followed with daily interviews, periodic physical examinations, measurements of vital signs, electrocardiograms, and serial laboratory studies. The study was accomplished without serious adverse effects although four drug related phenomenon were apparent. These alterations are as follows: Oral administration of WR-2721 at higher doses can cause nausea, emesis, abdominal cramps and diarrhea. Single doses of multiple one day doses of WR-2721 results in a decrease in serum calcium, increase in serum phosphate and an increase in the serum creatinine. These changes are definitely drug related, probably dose related, and were reversable in that the levels returned to pre drug levels by the time the study was completed. The mechanism by which these changes in laboratory parameters occurred is uncertain and was not in the object of this study. (Author)

Descriptors :   (*RADIOPROTECTIVE AGENTS, *TOXICITY), BIOASSAY, DOSAGE, DOSE RATE, INGESTION(PHYSIOLOGY), TOLERANCES(PHYSIOLOGY), HUMANS, PHARMACOLOGY

Subject Categories : Toxicology
      Pharmacology

Distribution Statement : APPROVED FOR PUBLIC RELEASE