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NCT00503490 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Cystic Fibrosis, sponsored by Amgen.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target
14
Study locations

NCT00503490 is a Phase 1 study of Cystic Fibrosis that has completed, run by Amgen. The registered enrollment target is 40 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (78% lower). The trial reports 14 study locations across 10 states.

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The verdict

NCT00503490, a Phase 1 study of Cystic Fibrosis, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target
14
Study locations

Study 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.

Conditions Studied

Cystic Fibrosis

Interventions

  • DRUG placebo
  • DRUG MP-376 (Levofloxacin solution for Inhalation)

Study Locations (14)

California

  • - La Jolla
  • - Los Angeles
  • - Palo Alto

New York

  • - Albany
  • - New Hyde Park

South Carolina

  • - Charleston
  • - Charleston

Florida

  • - Orlando

Michigan

  • - Kalamazoo

Nebraska

  • - Omaha

Ohio

  • - Columbus

Oklahoma

  • - Oklahoma City

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2007-06
Est. Completion 2007-12
Phase Phase 1

Sponsor

Amgen

558 total trials

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What the Registry Record Tells You About NCT00503490

The ClinicalTrials.gov registry entry for NCT00503490 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (78% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT00503490 reports 14 study locations spanning 10 distinct geographic areas - top geographies include California, New York, South Carolina.

Frequently Asked Questions

What is clinical trial NCT00503490 about?

NCT00503490 is a clinical study titled "Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis". 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...

What is the current status of trial NCT00503490?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2007-06. Estimated completion is 2007-12.

What conditions does trial NCT00503490 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT00503490?

The interventions under investigation include: placebo (DRUG), MP-376 (Levofloxacin solution for Inhalation) (DRUG).

Who is sponsoring clinical trial NCT00503490?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00503490 being conducted?

This trial has 14 study locations across California, Florida, Michigan, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.