Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment

pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of
delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic
impairment. AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz

Inclusion Criteria:

- Body mass index (BMI) between 18.5 and 40 kg/m2, inclusive.

- Able to provide written, informed consent before initiation of any study related
procedures, and is able, in the opinion of the investigator, to comply with all the
requirements of the study.

Hepatically Impaired Subjects Only (Groups A, B, and C):

-Has a clinical diagnosis of cirrhosis and has been classified as having mild (Group A),
moderate (Group B), or severe (Group C) hepatic impairment as defined by the Child-Pugh
classification system (Section 7.2).

Healthy Subjects Only (Group D):

-Must be in good health as determined by the investigator based on medical history,
clinical laboratory results, vital sign measurements, 12 lead electrocardiogram [ECG]
results, and physical examination findings

Exclusion Criteria:

- All Subjects (Groups A through D):

- Has a clinically significant abnormality in past medical history or at the screening
physical examination (excluding hepatic impairment and other related stable medical
conditions within the hepatically impaired population of subjects) that in the
investigator's or sponsor's opinion may place the subject at risk or interfere with
outcome variables of the study. This includes, but is not limited to, history or
current cardiac, renal, neurologic, gastrointestinal, respiratory, hematologic, or
immunologic disease.

- History or presence of an abnormal ECG that, in the investigator's opinion, is
clinically significant and would preclude study participation.

- Has any surgical or medical condition (active or chronic) that may interfere with
drug absorption, distribution, metabolism, or excretion of the study drug, or any
other condition that may place the subject at risk (history of cholecystectomy is
allowed).

- Has a functioning liver transplant

- Has a history of drug and/or alcohol abuse within 6 months before Screening

- Has a history of or current clinically significant mental disorder or an antagonistic
personality that compromises the validity of the informed consent.

- Has donated blood or plasma within 30 days before dosing, or has lost more than 1200
mL of blood within 4 months before the first dose of study drug.

- Has a history of AIDS or subject has positive results for HIV at Screening.

Hepatically Impaired Subjects Only (Groups A, B, and C):

- Has had clinical exacerbation of liver disease within 14 days before study drug
administration (eg, abdominal pain, ascites, nausea, vomiting, anorexia, fever, or
worsening of laboratory results related to hepatic function).

- Has evidence of acute viral hepatitis within 1 month before Day -1, has clinically
demonstrable massive tense ascites, has evidence of severe or acute renal failure,
has active stage 3 or stage 4 encephalopathy.

Healthy Subjects Only (Group D):

-Has a positive test result for hepatitis B surface antigen or hepatitis C virus antibody.