Elevation of Serum Transaminase Value after Administration of Non-toxic Drugs in Some Volunteers for Phase I Trials: A Study on the Selection of Volunteers.

1 January 1991

journal article
Published by Japanese Society of Clinical Pharmacology and Therapeutics in Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics

Vol. 22 (2) , 497-500
https://doi.org/10.3999/jscpt.22.497

Abstract

A total of 237 healthy male volunteers took drugs for phase I trials. Serum transaminase values (GOT and GPT) were maintained within normal ranges in most of them. However, GOT or GPT was elevated to an abnormal level in 9.3% of them after the administration.After investigating the clinical features of the “transaminase-elevated group” and the “non-elevated group”, we concluded that GOT or GPT is likely to be elevated in subjects with GOT<GPT, high obesity index, high serum γ-glutamyl transpeptidase, or a combination of any of the three. These subjects should be excluded from phase I trials for an accurate evaluation of the safety of a drug.

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