Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

"Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients"

This study has been completed.
Sponsor:
Information provided by:
Mpex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00840333
First received: February 5, 2009
Last updated: March 1, 2010
Last verified: March 2010
  Purpose

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. MP-376 is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery using the PARI electronic eFlow® nebulizer. Preclinical and early clinical studies in adults show that aerosol doses of MP-376 appear to be safe and well tolerated, and exert an antimicrobial effect when administered once or twice daily. High concentrations of levofloxacin in the lung delivered using MP-376 are expected to be active against CF pathogens such as P. aeruginosa and S. aureus, including those resistant to aminoglycosides (such as TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using the PARI eFlow® nebulizer system. This Phase 1 study is being performed to obtain safety, tolerability and PK data in children ages 6-16 in order to determine if MP-376 is safe, prior to enrolling children of these ages in the planned pivotal Phase 3 studies.


Condition Intervention Phase
Cystic Fibrosis
Drug: MP-376 (Levofloxacin solution for Inhalation)
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase 1B, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MP-376 Inhalation Solution Given Daily for 14 Days to Stable Pediatric Cystic Fibrosis Patients.

Resource links provided by NLM:


Further study details as provided by Mpex Pharmaceuticals:

Primary Outcome Measures:
  • Safety and Tolerability of MP-376 administered for 14 days to CF patients ages 6-16 [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum PK Profile of MP-376 administered for 14 days to CF patients ages 6-16 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Sputum PK Profile of MP-376 administered for 14 days to CF patients ages 6-16 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Evaluate changes in FEV1 and FVC from baseline to end of treatment [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Serum and sputum samples for PK measurements


Enrollment: 27
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
CF PATIENTS 6-11 YEARS OF AGE
Drug: MP-376 (Levofloxacin solution for Inhalation)
DOSE BASED ON PATIENTS WEIGHT
2
CF PATIENTS 12-16 YEARS OF AGE
Drug: MP-376 (Levofloxacin solution for Inhalation)
DOSE BASED ON PATIENTS WEIGHT

Detailed Description:

A Phase 1B, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MP-376 Inhalation Solution given Daily for 14 Days to Stable Pediatric Cystic Fibrosis Patients.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pedeatric CF patients ages 6-16 years of age

Criteria

Inclusion Criteria (selected):

  • 6 to 16 years of age (inclusive) at Visit 1
  • Weight is greater than or equal to 14 kilograms (kg)
  • Confirmed Diagnosis of Cystic Fibrosis
  • Patients are able to elicit an FEV1 >/= 25% of predicted value (Wang criteria)
  • Clinically stable with no changes in health status within the last 14 days
  • Able to reproducibly undergo spirometry testing

Exclusion Criteria (selected):

  • Use of any nebulized or systemic antibiotics within 7 days prior to baseline
  • History of intolerance or hypersensitivity to fluoroquinolones or intolerance with aerosol medications including bronchodilators
  • CrCl < 50mL/min/1.73m2, AST, ALT or total bilirubin >/= 3 x ULN at Screening or evidence of severe liver disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840333

Locations
United States, Alabama
Mobile, Alabama, United States
United States, California
San Diego, California, United States
United States, Florida
Orlando, Florida, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Missouri
Kansas City, Missouri, United States
United States, Ohio
Akron, Ohio, United States
Sponsors and Collaborators
Mpex Pharmaceuticals
Investigators
Principal Investigator: Gregory L Kearns, PharmD Childrens Mercy Hospitals and Clinics, Kansas City, MO
  More Information

No publications provided

Responsible Party: Elizabeth E. Morgan, Mpex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00840333     History of Changes
Other Study ID Numbers: Mpex-206
Study First Received: February 5, 2009
Last Updated: March 1, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Levofloxacin
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014