"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

February 5, 2009
March 1, 2010
April 2009
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00840333 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
"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.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum and sputum samples for PK measurements

Probability Sample

Pedeatric CF patients ages 6-16 years of age

Cystic Fibrosis
Drug: MP-376 (Levofloxacin solution for Inhalation)
DOSE BASED ON PATIENTS WEIGHT
  • 1
    CF PATIENTS 6-11 YEARS OF AGE
    Intervention: Drug: MP-376 (Levofloxacin solution for Inhalation)
  • 2
    CF PATIENTS 12-16 YEARS OF AGE
    Intervention: Drug: MP-376 (Levofloxacin solution for Inhalation)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00840333
Mpex-206
No
Elizabeth E. Morgan, Mpex Pharmaceuticals, Inc.
Mpex Pharmaceuticals
Not Provided
Principal Investigator: Gregory L Kearns, PharmD Childrens Mercy Hospitals and Clinics, Kansas City, MO
Mpex Pharmaceuticals
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP