A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin

Inclusion criteria

• Weighs at least 45 kg and body mass index of 18 to 40 kg/m2, inclusive
• An estimated creatinine clearance value based on Cockcroft-Gault method of:

• >80 mL/min for subjects with normal renal function
• <30 mL/min for subjects with severe renal impairment
• receiving hemodialysis three times a week for subjects with end stage renal impairment
• If female, the subject is at least 2 years postmenopausal, surgically sterile or practicing effective birth control, and is not pregnant or lactating
• Good venous access

Exclusion criteria

• History of any clinically significant acute illness (other than renal disease and conditions related to the renal disease in renal impairment subjects, such as stable diabetes or hypertension)
• Has had a kidney transplant that is still functioning
• History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmia or torsade de pointes, structural heart disease, prolonged QT interval, or family history of long QT syndrome
• Known hypersensitivity to telavancin or any of the excipients in the formulation, or a history of severe allergic or anaphylactic reactions
• History of consuming more than 7 units of alcoholic beverages per week, or history of alcoholism or substance abuse within past 2 years
• Known to be positive for human immunodeficiency virus antibody
• For subjects with normal renal function, has had treatment with prescription or non-prescription drugs, including complementary and alternative medicines or over-the counter medications, with the exception of oral contraceptives, hormone replacement therapy, daily aspirin, and occasional use of acetaminophen within the past 14 days
• For subjects with renal impairment, has not been on a stable dose of concomitant medications for at least 2 weeks prior to study start or is taking any medication that would interfere with the evaluation of televancin in this study
• Has received an experimental agent within 30 days or ten half-lives, whichever is longer, prior to study drug administration
• Has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission