"Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients"
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.
1 other identifier
interventional
27
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2009
Shorter than P25 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedDecember 4, 2024
December 1, 2024
8 months
February 5, 2009
December 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability of MP-376 administered for 14 days to CF patients ages 6-16
21 days
Secondary Outcomes (3)
Serum PK Profile of MP-376 administered for 14 days to CF patients ages 6-16
21 days
Sputum PK Profile of MP-376 administered for 14 days to CF patients ages 6-16
21 days
Evaluate changes in FEV1 and FVC from baseline to end of treatment
21 Days
Study Arms (2)
1
EXPERIMENTALCF PATIENTS 6-11 YEARS OF AGE
2
EXPERIMENTALCF PATIENTS 12-16 YEARS OF AGE
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (6)
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Akron, Ohio, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2009
First Posted
February 10, 2009
Study Start
April 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
December 4, 2024
Record last verified: 2024-12