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

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ClinicalTrials.gov Identifier: NCT00840333
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma USA, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: MP-376 (Levofloxacin solution for Inhalation) Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : April 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
CF PATIENTS 6-11 YEARS OF AGE
 Drug: MP-376 (Levofloxacin solution for Inhalation)
DOSE BASED ON PATIENTS WEIGHT
Experimental: 2
CF PATIENTS 12-16 YEARS OF AGE
 Drug: MP-376 (Levofloxacin solution for Inhalation)
DOSE BASED ON PATIENTS WEIGHT


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability of MP-376 administered for 14 days to CF patients ages 6-16 [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Serum PK Profile of MP-376 administered for 14 days to CF patients ages 6-16 [ Time Frame: 21 days ]
  2. Sputum PK Profile of MP-376 administered for 14 days to CF patients ages 6-16 [ Time Frame: 21 days ]
  3. Evaluate changes in FEV1 and FVC from baseline to end of treatment [ Time Frame: 21 Days ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840333


Locations
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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
Horizon Pharma USA, Inc.
Investigators
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Principal Investigator: Gregory L Kearns, PharmD Childrens Mercy Hospitals and Clinics, Kansas City, MO
More Information
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Responsible Party: Horizon Pharma USA, Inc.
ClinicalTrials.gov Identifier: NCT00840333    
Other Study ID Numbers: Mpex-206
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Levofloxacin
Ofloxacin
 Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors