Transaminase elevation on placebo during Phase I trials: prevalence and significance
- 1 July 1999
- journal article
- research article
- Published by Wiley in British Journal of Clinical Pharmacology
- Vol. 48 (1) , 19-23
- https://doi.org/10.1046/j.1365-2125.1999.00952.x
Abstract
Aims To evaluate the prevalence of transaminase elevation on placebo during Phase I trials. Methods Retrospective review of pooled transaminase data collected on placebo during 13 Phase I trials in 93 healthy volunteers hospitalized for 14 days, with determination of the prevalence of abnormally high values. Results 20.4% of the 93 subjects showed at least one ALT value above the upper limit of the normal range (ULN), and 7.5% had at least one value twice ULN. Conclusions Laboratory safety results of Phase I trials should be interpreted with caution, in the light of data on placebo, to avoid premature discontinuation of the development of safe drugs wrongly believed to be hepatotoxic.Keywords
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