Healthy Volunteers
Conditions
Brief summary
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.
Interventions
Administered via the Pari LC STAR™ nebulizer.
Sponsors
Insmed Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed