Dataset from A Phase I Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 in Subjects With Hepatic Impairment and Healthy Matched Control Subjects

This will be a Phase 1, open-label, parallel group, two-part, single-dose adaptive study in
adults with moderate and mild (if needed) hepatic impairment and matched, healthy control
subjects with normal hepatic function. In Part 1, healthy control subjects (n=8) matched to
subjects with moderate (n=8) hepatic impairment will be enrolled. If the geometric mean total
plasma area under the concentration-time curve from time zero (pre-dose) extrapolated to
infinite time (AUC[0-infinity]) of GSK1265744 is increased by >2-fold in moderately impaired
subjects relative to matched controls, Part 2 will be conducted to evaluate GSK1265744 PK in
subjects with mild hepatic impairment (n=8) and matched, control subjects (n=8). All subjects
will receive a single 30 milligram (mg) oral dose of GSK1265744. The primary objective of the
study is to compare plasma PK parameters of GSK1265744 in subjects with hepatic impairment to
healthy controls matched in gender, age, and body mass index (BMI).