Serum Transaminase Levels Should Be Measured Immediately Prior to Dosing in Early Phase I Clinical Trials | Zendy

Groen David | Zendy; Harris Stephen | Zendy; Colucci Salvatore | Zendy; Apseloff Glen | Zendy

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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.

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