Serum transaminase levels should be measured immediately prior to dosing in early phase I clinical trials.
J Clin Pharmacol
; 51(2): 252-5, 2011 Feb.
Article
em En
| MEDLINE
| ID: mdl-20354235
ABSTRACT
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Aspartato Aminotransferases
/
Ensaios Clínicos Fase I como Assunto
/
Alanina Transaminase
Idioma:
En
Ano de publicação:
2011
Tipo de documento:
Article