A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Liposomal Amikacin for Inhalation
- Registration Number
- NCT05999942
- Lead Sponsor
- Insmed Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Amikacin Liposome Inhalation Liposomal Amikacin for Inhalation Participants will receive a single dose of radiolabelled amikacin loaded liposomes by inhalation on Day 1.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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