Prevalence of abnormal liver-associated enzymes in cocaine experienced adults versus healthy volunteers during Phase 1 clinical trials

In conclusion, despite normal baseline values, most subjects demonstrated an increase in the ALT level even on placebo. For CE subjects, differences (▵ALT and ▵AST) between baseline and the maximum observed values were significantly higher than that observed for HN subjects. The potential to obscure important signals for hepatotoxicity during Phase 1 research may be higher in the CE study population.