P Rosenzweig1, N Miget, S Brohier. 1. Department of Clinical Pharmacology, Synthélabo Recherche, 31 avenue Paul Vaillant-Couturier, 92225 Bagneux Cedex, France.
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.
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.
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