Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Phase I, Single and Multi-dose, Placebo Controlled, Randomized, Dose-Escalation Study to Evaluate the Safety, Tolerability and PK Profile of MP-376 Using the PARI eFlow Nebulizer for 14 Days to CF Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503490
• Other study ID #: Mpex-203
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2007
• Last updated: January 17, 2018
• Start date: June 2007
• Est. completion date: December 2007

Study information

• Verified date: January 2018
• Source: Horizon Pharma USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and reduce the emergence of resistant bacteria.

Description:

This trial will be a single-blind, placebo-controlled, dose escalating between cohorts, single and multi-dose, multi-center study to evaluate the safety, tolerability and pharmacokinetic profile of levofloxacin administered as MP-376 once, then twice daily for 14 days by the aerosol route to CF patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• > 16 years of age

• Confirmed Diagnosis of Cystic Fibrosis

• Positive sputum culture for P. aeruginosa within the past 6 months

• Patients are able to elicit an FEV1 >/= 40% of predicted value at screening

• Clinically stable with no evidence of acute respiratory or lower respiratory infections within 28 days prior to dosing

• Able to reproducibly perform spirometry measurements and be able to repeatedly produce sputum over several hours

Exclusion Criteria:

• Use of any nebulized or systemic antibiotics within 4 weeks of starting study

• History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication

• Uncontrolled diabetes or abnormal renal function

• Tobacco use (smoking) in the last 30 days

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• MP-376 (Levofloxacin solution for Inhalation)
40, 80, 120mg RDD
• placebo
BID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Horizon Pharma USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of MP-376 administered twice a day for 14 days		14 days
Secondary	Evaluate changes in the microbiology of CF sputum after 14 days of treatment with MP-376		14 days
Secondary	PK Profile of single-dose vs multi-dose of MP-376		14 days
Secondary	Evaluate changes in FEV1 and FVC over 14 days of Treatment		14 days