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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00503490
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma USA, Inc.

Tracking Information
First Submitted Date  ICMJE July 16, 2007
First Posted Date  ICMJE July 18, 2007
Last Update Posted Date January 19, 2018
Study Start Date  ICMJE June 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2007)
Safety and tolerability of MP-376 administered twice a day for 14 days [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2007)
Safety and tolerability of MP-376 administered twice a day for 14 days
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2007)
  • Evaluate changes in the microbiology of CF sputum after 14 days of treatment with MP-376 [ Time Frame: 14 days ]
  • PK Profile of single-dose vs multi-dose of MP-376 [ Time Frame: 14 days ]
  • Evaluate changes in FEV1 and FVC over 14 days of Treatment [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2007)
  • Evaluate changes in the microbiology of CF sputum after 14 days of treatment with MP-376
  • PK Profile of single-dose vs multi-dose of MP-376
  • Evaluate changes in FEV1 and FVC over 14 days of Treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis
Official Title  ICMJE 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
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 and reduce the emergence of resistant bacteria.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • Drug: MP-376 (Levofloxacin solution for Inhalation)
    40, 80, 120mg RDD
  • Drug: placebo
    BID
Study Arms  ICMJE
  • Experimental: 1
    Inhaled Levofloxacin
    Intervention: Drug: MP-376 (Levofloxacin solution for Inhalation)
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2008)
40
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2007)
39
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00503490
Other Study ID Numbers  ICMJE Mpex-203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Horizon Pharma USA, Inc.
Study Sponsor  ICMJE Horizon Pharma USA, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Horizon Pharma USA, Inc.
Verification Date January 2018

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