Dataset from A Phase I, Open-Label, Single-Dose, Two-Part Study to Assess the Pharmacokinetics of Gepotidacin (GSK2140944) in Male and Female Adult Participants With Varying Degrees of Hepatic Impairment and in Matched Control Participants With Normal Hepatic Function

This is a two-part study which will evaluate the PK, safety, and tolerability of a single
1500 milligram (mg) oral dose of gepotidacin in subjects with normal hepatic function and in
subjects with mild, moderate, and severe hepatic impairment. In Part 1, subjects with
moderate hepatic impairment and subjects with normal hepatic function will be enrolled.
Matching subjects with normal hepatic function in Part 1 (Group D), will be enrolled
following the completion of all Day 3 assessments of the respective matched, hepatically
impaired subject. In Part 2, subjects with mild (optional) and severe hepatic impairment and
subjects with normal hepatic function will be enrolled concurrently based on the PK, safety,
and tolerability data of Part 1. Subjects with mild hepatic impairment, may be studied if
there is a significant difference in PK between subjects with moderate hepatic impairment and
subjects with normal hepatic function. Subjects with severe hepatic impairment, will be
studied in Part 2, provided that, the PK objectives are achieved in Part 1. A totals of 48
subjects, are planned to be enrolled in the study. The study duration is approximately of 44
days from Screening to Follow-up visit. The results from this study will enable the
development of appropriate dosing recommendations in subjects with impaired hepatic function.