Cystic FibrosisPhase 1NCT00840333
"Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients"
A Phase 1 study testing MP-376 (Levofloxacin solution for Inhalation) in people with Cystic Fibrosis, run by Amgen at 6 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 6 to 16 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- MP-376 (Levofloxacin solution for Inhalation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2009to Dec 2009
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Akron, Ohio
Study site
Kansas City, Missouri
Study site
Louisville, Kentucky
Study site
Mobile, Alabama
Study site
Orlando, Florida
Study site
San Diego, California
About this study
Official title: 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.
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.
Read the 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
- Being tested
- MP-376 (Levofloxacin solution for Inhalation)
- 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
DOSE BASED ON PATIENTS WEIGHT
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CF PATIENTS 6-11 YEARS OF AGE Receives: Drug: MP-376 (Levofloxacin solution for Inhalation) |
| 2 | Experimental | CF PATIENTS 12-16 YEARS OF AGE Receives: Drug: MP-376 (Levofloxacin solution for Inhalation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of MP-376 administered for 14 days to CF patients ages 6-16
Measured: 21 days
Secondary outcomes (3)
Serum PK Profile of MP-376 administered for 14 days to CF patients ages 6-16
Measured: 21 days
Sputum PK Profile of MP-376 administered for 14 days to CF patients ages 6-16
Measured: 21 days
Evaluate changes in FEV1 and FVC from baseline to end of treatment
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionDec 2009
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
- None (open label)
- Enrolment
- 27 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
- NCT00840333
- Sponsor's protocol ID
- Mpex-206
- Status last verified
- Dec 2024
- First submitted
- 5 Feb 2009
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
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
- 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.
- ClinicalTrials.gov ID
- NCT00840333
- Acronym / sponsor ID
- Mpex-206
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Feb 2009 (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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MP-376 (Levofloxacin solution for Inhalation)CF PATIENTS 6-11 YEARS OF AGE |
| 2 | Experimental | Drug: MP-376 (Levofloxacin solution for Inhalation)CF PATIENTS 12-16 YEARS OF AGE |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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)DOSE BASED ON PATIENTS WEIGHT | Drug | 1, 2 |
Primary outcome
Safety and Tolerability of MP-376 administered for 14 days to CF patients ages 6-16
Time frame: 21 days
3 secondary outcomes
Serum PK Profile of MP-376 administered for 14 days to CF patients ages 6-16
Time frame: 21 days
Sputum PK Profile of MP-376 administered for 14 days to CF patients ages 6-16
Time frame: 21 days
Evaluate changes in FEV1 and FVC from baseline to end of treatment
Time frame: 21 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
6 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 6 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 3 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 6 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. 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 for 14 days to CF patients ages 6-16 (time frame: 21 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.