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

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

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.

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.