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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Liposomal Amikacin for Inhalation

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amikacin Liposome Inhalation; Participants will receive a single dose of radiolabelled amikacin loaded liposomes by inhalation on Day 1.	Drug: Liposomal Amikacin for Inhalation; Administered via the Pari LC STAR™ nebulizer.; Other Names: Amikacin Liposome Inhalation Suspension (ALIS),; Arikayce™

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Insmed Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2004
• Primary Completion (Actual): June 29, 2004
• Study Completion (Actual): June 29, 2004

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Amikacin
• Other Study ID Numbers: RD 201/23924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No