"Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients"
Information source: Mpex Pharmaceuticals
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: MP-376 (Levofloxacin solution for Inhalation) (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Mpex Pharmaceuticals Official(s) and/or principal investigator(s):
Gregory L Kearns, PharmD, Principal Investigator, Affiliation: Childrens Mercy Hospitals and Clinics, Kansas City, MO
Overall contact:
Elizabeth E Morgan, Phone: 858-875-6671, Email: lmorgan@mpexpharma.com
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Primary outcome: Safety and Tolerability of MP-376 administered for 14 days to CF patients ages 6-16
Secondary outcome: Serum PK Profile of MP-376 administered for 14 days to CF patients ages 6-16Sputum PK Profile of MP-376 administered for 14 days to CF patients ages 6-16 Evaluate changes in FEV1 and FVC from baseline to end of treatment
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
Minimum age: 6 Years.
Maximum age: 16 Years.
Gender(s): Both.
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% but
- Clinically stable with no changes in health status within the last 30 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
Locations and Contacts
Elizabeth E Morgan, Phone: 858-875-6671, Email: lmorgan@mpexpharma.com
Mobile, Alabama, United States
San Diego, California, United States
Orlando, Florida, United States
Detroit, Michigan, United States
Kansas City, Missouri, United States
Cleveland, Ohio, United States
Akron, Ohio, United States
Additional Information
Starting date: February 2009
Ending date: December 2009
Last updated: February 6, 2009
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