Low dose human APAP exposure

Acetaminophen is the primary cause of acute liver toxicity in Europe/USA. Therefore, the FDA reconsiders recommendations concerning safe acetaminophen dosage/use. Current tests for liver toxicity are no ideal predictive markers for liver injury. Here, ‘omics techniques (global analysis of metabolomic/gene expression responses) may provide additional insight. To better understand acetaminophen-induced responses at low dose, we evaluated effects of (sub-)therapeutic acetaminophen doses on metabolite formation/global gene-expression changes (including, for the first time, miRNA) in blood/urine samples from healthy human volunteers. Three dose rounds with 6 individuals were performed with 0.5, 2 or 4 g APAP. In the 0.5 and 2 g dose-rounds T0(control) T1, T7 and T25 samples were collected in the 4g round only T0(control) and T25 samples are available.