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

NCT00645437 | Completed Phase 1

• 1 other identifier: CR004174
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Diseases

Keywords

renal diseases; levofloxacin

Outcome Measures

Primary Outcomes (1)

• Evaluation of the pharmacokinetics of two dosing regimens of levofloxacin in renally impaired and dialysis patients.

Secondary Outcomes (1)

• Safety of two dosing regimens of levofloxacin in renally impaired and dialysis patients.

Interventions

Levofloxacin DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• An Open-Label Randomized Multiple-Dose Study to Evaluate Levofloxacin Steady-State Pharmacokinetics and Safety in Subjects With Varying Degrees of Renal Function

MeSH Terms

Conditions

Kidney Diseases

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 27, 2008
• Study Start: October 1, 2004
• Study Completion: April 1, 2006
• Last Updated: June 8, 2011

Record last verified: 2010-04