A human AME (hAME) phase I study administers a radiolabeled compound to evaluate the total fate of drug-related material (represented by the radiolabel). 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.
Human AME studies aim to characterize any circulating metabolites greater than 10% of the AUC (area under the curve) of drug-related material and more than 80% of the recovered radioactivity from excreta.
- Safety Testing of Drug Metabolites
- ICH M3 (R2)
- EMA DDI