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Serum Transaminase Levels Should Be Measured Immediately Prior to Dosing in Early Phase I Clinical Trials
Author(s) -
Groen David,
Harris Stephen,
Colucci Salvatore,
Apseloff Glen
Publication year - 2011
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270010365548
Subject(s) - dosing , transaminase , alanine aminotransferase , alanine transaminase , clinical trial , medicine , aspartate transaminase , elevated transaminases , pharmacology , chemistry , enzyme , biochemistry , alkaline phosphatase
Observations of predose spikes in transaminases from a phase I study prompted our review of other clinical trials, including 250 healthy participants from 4 studies at 3 sites. Six of these participants (2.4%) displayed elevated alanine aminotransferase/aspartate aminotransferase (ALT/AST) levels immediately predose despite normal values <48 hours previously, including one with ALT/AST = 237/175 IU/L (previously 41/29 IU/L). Testing immediately prior to dosing can exonerate a study drug and avoid unnecessary, expensive delays in early clinical trials.