Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics and Safety of Levofloxacin in Patients With Varying Degrees of Renal Function.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Renal Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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.
Detailed Description
In this multiple-dose study conducted at 4 centers, the pharmacokinetics of two dosing regimens of levofloxacin were assessed in medically stable men and women with varying degree of renal function. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00645437
Start Date
October 1 2004
End Date
April 1 2006
Last Update
June 8 2011
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