Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

Inclusion criteria

• Subjects who signed informed consent.
• Male subjects ≥18 and ≤79 years of age; female subjects ≥18 and ≤79 years of age of non-childbearing potential
• Weight within a BMI range of 19.0-35.0 kg/m2.
• CLCr according to Cockcroft Gault equation of:

• 50-80 mL/min (mild renal impairment)
• 30- <50 mL/min (moderate renal impairment)
• <30 mL/min (severe renal impairment)
• subjects receiving dialysis for ≥3 months before dosing (ESRD)
• >80 mL/min (normal renal function)

Exclusion criteria

• Unwilling or unable to give informed consent.
• As a result of the medical screening process, the study physician considers the subject unfit for the study.
• Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day).
• Subjects who smoke more than 10 cigarettes a day.
• Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week.
• Any history of hypersensitivity to the IMP.
• For subjects with renal impairment: No clinically significant change in disease status within at least 1 month prior to study entry, as determined by the investigator.
• The subject had donated a unit of blood (450 mL) within the 3 months before dosing, or intends to donate in the month after the last scheduled visit.
• Participation in another clinical study with an investigational drug or device within the last month.
• Subjects with clinically significant telemetric ECG abnormalities on Day -1
• Significant allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction.
• Positive test for human immunodeficiency virus (HIV) antibodies.
• Acute Hepatitis B or C infection.
• The subject has tested positive for drugs of abuse at screening.
• Subjects who have received any prescribed systemic or topical medication within 4 weeks prior to dosing (excluded are those drugs the renally impaired subject is currently taking for treatment of the renal or concomitant disease).
• Immunocompromised patients (patients after solid organ or bone marrow transplant; patients receiving immunosuppressive treatment).
• Subjects with known or suspected Pseudomonas infection or colonization (e.g. patients with cystic fibrosis).
• Subjects with significant liver function abnormalities
• Subjects with acute myocardial infection or unstable angina pectoris