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

NCT ID: NCT00840333

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-12-31

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.

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 acquired from Horizon in 2024.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

CF PATIENTS 6-11 YEARS OF AGE

Group Type: EXPERIMENTAL

MP-376 (Levofloxacin solution for Inhalation)

Intervention Type: DRUG

DOSE BASED ON PATIENTS WEIGHT

2

CF PATIENTS 12-16 YEARS OF AGE

Group Type: EXPERIMENTAL

MP-376 (Levofloxacin solution for Inhalation)

Intervention Type: DRUG

DOSE BASED ON PATIENTS WEIGHT

Interventions

MP-376 (Levofloxacin solution for Inhalation)

DOSE BASED ON PATIENTS WEIGHT

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Mobile, Alabama, United States

San Diego, California, United States

Orlando, Florida, United States

Louisville, Kentucky, United States

Kansas City, Missouri, United States

Akron, Ohio, United States

Countries

United States

Other Identifiers

Mpex-206

Identifier Type: -

Identifier Source: org_study_id