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This is a randomized, double-blind, cross-over, vehicle-controlled study to determine whether GS-5737 in 2.8% saline accelerates mucociliary clearance (MCC) in healthy subjects, compared to vehicle of 2.8% saline alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cross-Over Sequence 1 | Experimental | 85 μg GS-5737 in 2.8% saline or 2.8% saline alone (blinded) |
|
| Cross-Over Sequence 2 | Experimental | 2.8% saline alone or 85 μg GS-5737 in 2.8% saline (blinded) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-5737 | Drug | A single dose of GS-5737 in 2.8% saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve of MCC from Whole Lung Compartment | The primary endpoint of this study will be the calculated area under the curve of MCC from the whole lung compartment, assessed through 60 minutes post isotope dosing (AUC-60min), which will provide a description of the MCC curve. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve of MCC from Central and Peripheral Lung | This outcome measure will be the calculated area under the cuve of MCC from the central and peripheral lung assessed through 60 minutes post isotope dosing (AUC60min). | 4 weeks or duration of study |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of GS-5737 | Adverse events, airway reactivity, pulse oximetry, physical examination, and clinical laboratory test findings, urine and plasma potassium levels, 12-lead ECG abnormalities and interval measurements, and vital sign measurements will be used to assess this outcome measure. | 4 weeks or duration of study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Bresnik, M.D. | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |