Human absorption, metabolism and excretion (hAME)

A human AME (hAME) phase I study administers a radiolabeled compound to evaluate the total fate of drug-related material. The study assesses the pharmacokinetics, mass balance, routes of excretion and metabolic pathways of the parent drug to ensure that the metabolite profile is comparable to what was seen in preclinical ADME studies and to identify any disproportionate or unique human metabolites. These studies are often conducted between Phase II/III and typically involve healthy human volunteers in UK and the U.S. facilities that are located close to the labs, so samples can be quickly processed.