Elevated Serum Transaminase Values in Volunteers after Administration of Placebo in a Phase I Study.

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Abstract
Serum transaminase (AST and ALT) values were monitored after administration of placebo to 104 healthy male volunteers for a phase I study. Both values remained within normal ranges in most of them. However, AST or ALT was above the normal range in 13 volunteers (12.5%). Their clinical features were ALT>AST, high serum γ-glutamyl trans peptidase, high serum triglyceride, high obesity index, or a combination of any of the four. We concluded that AST or ALT is likely elevated in volunteers showing these clinical signs; this should be noted in the evaluation of drug toxicity in future phase I studies.

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