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Completed

NCT Number: NCT00503490

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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MP-376 (Levofloxacin solution for Inhalation)

Drug

40, 80, 120mg RDD

Placebo

Drug

BID

Primary outcomes

  1. Safety and tolerability of MP-376 administered twice a day for 14 days

    Time frame: 14 days

Secondary outcomes

  1. Evaluate changes in the microbiology of CF sputum after 14 days of treatment with MP-376

    Time frame: 14 days

  2. PK Profile of single-dose vs multi-dose of MP-376

    Time frame: 14 days

  3. Evaluate changes in FEV1 and FVC over 14 days of Treatment

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Phase I, Single and Multi-dose, Placebo Controlled, Randomized, Dose-Escalation Study to Evaluate the Safety, Tolerability and PK Profile of MP-376 Using the PARI eFlow Nebulizer for 14 Days to CF Patients

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 18, 2007
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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