Cystic FibrosisPhase 1NCT00503490
Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis
A Phase 1 study testing MP-376 (Levofloxacin solution for Inhalation) in people with Cystic Fibrosis, run by Amgen at 14 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- MP-376 (Levofloxacin solution for Inhalation)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 14 sitesUnited States
- Study dates
- Jun 2007to Dec 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Study site
Albany, New York, 12208
Study site
Charleston, South Carolina, 29203
Study site
Charleston, South Carolina, 29425
Study site
Columbus, Ohio, 43205
Study site
Kalamazoo, Michigan, 49007
Study site
La Jolla, California, 92037
Study site
Los Angeles, California, 90033
Study site
New Hyde Park, New York, 11040
Study site
Oklahoma City, Oklahoma, 73112
Study site
Omaha, Nebraska, 68154
Study site
Orlando, Florida, 32801
Study site
Palo Alto, California, 94303
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78212
About this study
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
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.
Read the 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 acquired from Horizon in 2024.
- Conditions
- Cystic Fibrosis
- Being tested
- MP-376 (Levofloxacin solution for Inhalation), placebo
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP-376 (Levofloxacin solution for Inhalation)Drug
40, 80, 120mg RDD
placeboDrug
BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Inhaled Levofloxacin Receives: Drug: MP-376 (Levofloxacin solution for Inhalation) |
| 2 | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of MP-376 administered twice a day for 14 days
Measured: 14 days
Secondary outcomes (3)
Evaluate changes in the microbiology of CF sputum after 14 days of treatment with MP-376
Measured: 14 days
PK Profile of single-dose vs multi-dose of MP-376
Measured: 14 days
Evaluate changes in FEV1 and FVC over 14 days of Treatment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503490
- Sponsor's protocol ID
- Mpex-203
- Status last verified
- Dec 2024
- First submitted
- 16 Jul 2007
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00503490
- Acronym / sponsor ID
- Mpex-203
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 acquired from Horizon in 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MP-376 (Levofloxacin solution for Inhalation)Inhaled Levofloxacin |
| 2 | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MP-376 (Levofloxacin solution for Inhalation)40, 80, 120mg RDD | Drug | 1 |
| placeboBID | Drug | 2 |
Primary outcome
Safety and tolerability of MP-376 administered twice a day for 14 days
Time frame: 14 days
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MP-376 (Levofloxacin solution for Inhalation) in people with Cystic Fibrosis, run by Amgen at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of MP-376 administered twice a day for 14 days (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.