Status:
COMPLETED
"Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients"
Lead Sponsor:
Amgen
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-16 years
Phase:
PHASE1
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 partic...
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....
Eligibility Criteria
Inclusion
- Inclusion Criteria (selected):
- 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
- Exclusion Criteria (selected):
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00840333
Start Date
April 1 2009
End Date
December 1 2009
Last Update
December 4 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Mobile, Alabama, United States
2
San Diego, California, United States
3
Orlando, Florida, United States
4
Louisville, Kentucky, United States