Studies in early clinical development
5. Hepatic Impairment Study
The objective of hepatic impairment studies is to evaluate the medicine in people who have different levels of hepatic (liver) impairment.
If Pharmacokinetic results are linear and time-independent, then hepatic impairment studies are typically run as parallel group studies with healthy male and female volunteers (n ≥8 (full study) or n ≥6 (reduced study)) who have varying degrees of impairment of hepatic function. The groups are stratified based on Child-Pugh score classification in to: normal, mild, moderate, and severe impairment.
If the medicine is metabolised by an enzyme that only occurs through genetic variants, then participants should be assessed based on their genotype status.
The information gained from hepatic impairment studies: