Title
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
Phase
Phase 1Lead Sponsor
Insmed, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Healthy VolunteersIntervention/Treatment
Liposomal Amikacin for InhalationStudy Participants
6The 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.
Administered via the Pari LC STAR™ nebulizer.
Participants will receive a single dose of radiolabelled amikacin loaded liposomes by inhalation on Day 1.
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.
