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The purpose of this study is to evaluate the safety and tolerability of a new inhaled sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be inhaled once a day for 14 days using a nebulizer. A small subgroup of patients will donate blood samples for pharmacokinetic analysis to see how 552-02 is absorbed into the blood and eliminated after 14 days of treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 552-02 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments | ||
| Blood and urine laboratory tests | ||
| Pulmonary function tests | ||
| Electrocardiograms | ||
| Vital signs and pulse oximetry |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics on Day 14 of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Diego | San Diego | California | 92161 | United States | ||
| University of California at San Francisco Medical Center |
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| San Francisco |
| California |
| 94143-0359 |
| United States |
| The Children's Hospital | Denver | Colorado | 80218 | United States |
| Nemours Children's Clinic | Orlando | Florida | 32806-1101 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-5190 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| State University of New York Upstate | Syracuse | New York | 13210 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4399 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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