Abstract
Healthy adults are generally recruited for first-in-human clinical trials. However, their inclusion/exclusion criteria are not easily applied to trials for the elderly. Reference values were modified by 10–20% in screening tests to investigate the usefulness of the age-adjusted inclusion/exclusion criteria. Seven items were modified, including fasting blood sugar (FBS) and systolic blood pressure (SBP). Of the 28 screening failures, modified FBS caused 11 screening failure cases with no concomitant medication. Elevated SBP affected few concomitant medication cases in the middle-aged. Age-adjusted reference values maintained the inclusion/exclusion criteria of healthy elderly Korean participants by rendering the concomitant medication issue clinically insignificant.
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