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Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis

NCT ID: NCT00503490

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-12-31

Brief Summary

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Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms and reduce the emergence of resistant bacteria.

Detailed Description

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This trial will be a single-blind, placebo-controlled, dose escalating between cohorts, single and multi-dose, multi-center study to evaluate the safety, tolerability and pharmacokinetic profile of levofloxacin administered as MP-376 once, then twice daily for 14 days by the aerosol route to CF patients.

Study acquired from Horizon in 2024.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Inhaled Levofloxacin

Group Type EXPERIMENTAL

MP-376 (Levofloxacin solution for Inhalation)

Intervention Type DRUG

40, 80, 120mg RDD

2

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

BID

Interventions

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MP-376 (Levofloxacin solution for Inhalation)

40, 80, 120mg RDD

Intervention Type DRUG

placebo

BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \> 16 years of age
* Confirmed Diagnosis of Cystic Fibrosis
* Positive sputum culture for P. aeruginosa within the past 6 months
* Patients are able to elicit an FEV1 \>/= 40% of predicted value at screening
* Clinically stable with no evidence of acute respiratory or lower respiratory infections within 28 days prior to dosing
* Able to reproducibly perform spirometry measurements and be able to repeatedly produce sputum over several hours

Exclusion Criteria

* Use of any nebulized or systemic antibiotics within 4 weeks of starting study
* History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
* Uncontrolled diabetes or abnormal renal function
* Tobacco use (smoking) in the last 30 days
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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La Jolla, California, United States

Site Status

Los Angeles, California, United States

Site Status

Palo Alto, California, United States

Site Status

Orlando, Florida, United States

Site Status

Kalamazoo, Michigan, United States

Site Status

Omaha, Nebraska, United States

Site Status

Albany, New York, United States

Site Status

New Hyde Park, New York, United States

Site Status

Columbus, Ohio, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Charleston, South Carolina, United States

Site Status

Charleston, South Carolina, United States

Site Status

San Antonio, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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Mpex-203

Identifier Type: -

Identifier Source: org_study_id