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The primary purpose of this study is to determine the intra and extra pulmonary deposition and clearance of inhaled amikacin-loaded liposomes by gamma scintigraphy in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amikacin Liposome Inhalation | Experimental | Participants will receive a single dose of radiolabelled amikacin loaded liposomes by inhalation on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Amikacin for Inhalation | Drug | Administered via the Pari LC STAR™ nebulizer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Deposition of Radiolabelled Amikacin-loaded Liposomes Measured as Percentage Retention of Emitted Dose Deposited in the Lungs | Pre-administration and 2 hours post-administration on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Dose Deposited in Oropharyngeal and Stomach Region | At multiple timepoints post-administration up to Day 2 | |
| Percent Dose Remaining in the Device Including the Mouthpiece | At multiple timepoints post-administration up to Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion/exclusion criteria may apply.
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| Percent Dose Remaining in the Low Resistance Exhalation Filter | At multiple timepoints post-administration up to Day 2 |
| Penetration Index Based on the Ratio of Counts in the Central:Peripheral Lung Regions, Corrected for Regional Lung Volume (sC/P) | Pre-administration and 2 hours post- administration on Day 1 |