A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Gamma Scintigraphy Study to Investigate the Lung Deposition of Inhaled Amikacin-Loaded Liposomes in Healthy Male Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Liposomal Amikacin for Inhalation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with a body mass index (BMI) of 20-28. Participants with negative human immunodeficiency virus (HIV) and Hepatitis B and C results. Participants with no clinically significant findings in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study. Exclusion Criteria: Participants who had clinically diagnosed asthma. Participants with a known allergic reaction to amikacin, liposomes or any of the radiolabelling products (i.e. [^99m]Tc, or [^111]In, and [^81m]Kr). Evidence of clinically significant pulmonary, renal, hepatic, cardiovascular or metabolic dysfunction. History of smoking within the past 12 months. History of chronic cough or wheezing within the previous 21 days. Participants who had an upper respiratory illness or infection within the previous 21 days. A history of drug or alcohol abuse. Donation of 450 milliliters (mL) or more blood within the previous 12 weeks. Note: Other inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amikacin Liposome Inhalation<br>Participants will receive a single dose of radiolabelled amikacin loaded liposomes by inhalation on Day 1. | Drug: Liposomal Amikacin for Inhalation<br>* Administered via the Pari LC STAR™ nebulizer.<br>* Other names: Arikayce™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |