Abstract
History-taking, physical examination, laboratory tests, and electrocardiography (ECG) were performed in 744 male volunteers (20-28, mean 21 years old). In 228 of 577 (39.5%) volunteers in whom all of the above examinations could be performed, some kinds of abnormalities were recognized. The abnormalities included ECG findings (149/577, 25.8%), laboratory tests (37/577, 6.4%), physical examinations (7/577, 2.1%), past/familiar histories (23/577, 4.0%), and others (12/577, 2.1%). Regarding the incidence of ECG abnormalities, left ventricular hypertrophy was the most common (18.9%), followed by sinus arrythmia (12.3%) and incomplete right bundle branch block (8.3%). The W-P-W syndrome (8/228, 3.5%), complete right bundle branch block (6/228, 2.6%), and first degree of atrioventricular block (5/228, 2.2%) were in particular first noted in this study. In the laboratory tests, the greatest incidence of abnormality was recognized in the positive HBs antigen (16/744, 2.2%), with proteinuria (6/577, 1.0%) next, and the other abnormalities being less than 1.0%.
The present study indicated a high incidence of abnormalities in the physical/laboratory findings even in asymptomatic young males who felt healthy. Therefore, it is suggested that further assessment of standardization and evaluations of screening tests of “normal and healthy” volunteers should be strictly made especially for the choice of volunteers who would participate in Phase I studies of the safety of newly developed drugs.
