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

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00645437

Purpose

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

Condition	Intervention	Phase
Renal Diseases	Drug: Levofloxacin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Randomized Multiple-Dose Study to Evaluate Levofloxacin Steady-State Pharmacokinetics and Safety in Subjects With Varying Degrees of Renal Function

Resource links provided by NLM:

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	59
Study Start Date:	October 2004
Study Completion Date:	April 2006

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. The study consisted of a 21 day pretreatment screening phase, a 7-day open label treatment phase, and a 7 day posttreatment phase (or a follow-up phase for subjects with early study withdrawal). Patients were randomized into 1 of 10 treatment groups, for a total of 6 patients per group, based on degree of renal function to ensure that creatinine clearance values within each group represented the full range of values defined in the Food and Drug Administration's (FDA) 1998 guideline for pharmacokinetic studies in patients with impaired renal function. Fifty-nine patients were enrolled in the study. All patients received a single 750-mg dose of levofloxacin on Day 1; subsequent doses of either 250, 500, or 750 mg of levofloxacin (q24h or q48h) were based on renal function. Blood samples were collected from each patient from Day 1 to Day 14 for pharmacokinetic evaluation. Urine was collected on Days 1 and 7 before dosing and over specific time intervals up to 24 or 48 hours postdosing depending on the patient's dosing regimen. Dialysate samples were collected on Day 7 from HD patients immediately before dosing (as dialysis began) and at the end of the dialysis treatment. Patients were confined overnight at the study unit on Days 0, 1, 6, and 7, and remained confined until the 24 hour blood samples were collected on Days 2 and 8. Safety was based on the incidence, relationship to therapy, and severity of treatment-emergent adverse events and on changes in clinical laboratory values (hematology, chemistry, and urinalysis), vital sign measurements, electrocardiograms (ECGs), and physical examination findings. Single 750-mg dose of levofloxacin on Day 1; subsequent doses of Levofloxacin 250 milligram (mg), 500 mg, and 750 mg tablets administered every 24 hours for 7 days or every 48 hours for 7 days

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645437

Sponsors and Collaborators

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

Investigators

Study Director:

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

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

More Information

Additional Information:

An Open-Label Randomized Multiple-Dose Study to Evaluate Levofloxacin Steady-State Pharmacokinetics and Safety in Subjects With Varying Degrees of Renal Function This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00645437 History of Changes
Other Study ID Numbers:	CR004174
Study First Received:	March 24, 2008
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

renal diseases
levofloxacin

Additional relevant MeSH terms:

Kidney Diseases
Urologic Diseases
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on February 09, 2012