A Study to Evaluate the Pharmacokinetics and Safety of Levofloxacin in Patients With Varying Degrees of Renal Function.

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to evaluate the pharmacokinetics and safety of two dosing regimens of levofloxacin in patients with varying degrees of renal function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• BMI between 18 and 35 kg/m2

• No prescription or over-the-counter medications for previous 7 days

• Negative tests for drug and alcohol abuse, HIV, hepatitis B and hepatitis C

• Medically stable based on medical history, physical examination, 12-lead electrocardiograms, toxicology, antigen, and antibody screens, and clinical laboratory evaluations

• Stable renal function based on calculated creatine clearance for non-dialysis patients and the same dialysis treatment for at least 6 months prior to screening for dialysis patients

• Patients with creatinine clearance =80 mL/min who require treatment for renal impairment or other chronic disease (e.g., well-controlled diabetes, hypertension) must be on a stable treatment plan (medicines, doses, and regimens) for at least 2 months prior to Day 1 and during the entire study

• Hematocrit (hct) within the normal range based on patients' renal function at screening

Exclusion Criteria:

• Allergic reaction to quinolones

• Known or suspected allergy to heparin

• Clinically significant ECG or clinical laboratory abnormalities

• Creatinine clearance <80 mL/min whose medical condition was unstable

• creatinine clearance >= 80 mL/min who required concomitant medication during the study

• Poorly controlled type 1 or type 2 diabetes

• Patients with creatinine clearance >= 50 mL/min with screening blood pressure outside the normal range (sitting systolic blood pressure <90 or >140 mm mercury [Hg] or diastolic blood pressure <60 or >90 mm Hg)

• Patients with CLCR <50 mL/min who had sitting systolic blood pressure <90 or >160 mm Hg, or diastolic blood pressure <60 or >90 mm Hg

• Required warfarin treatment

• Required immunosuppressive medications for treatment of immune-mediated renal disease or kidney transplant

• Pregnant or breastfeeding.