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

NCT05999942 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: RD 201/23924
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Amikacin Liposome Inhalation

EXPERIMENTAL

Participants will receive a single dose of radiolabelled amikacin loaded liposomes by inhalation on Day 1.

Drug: Liposomal Amikacin for Inhalation

Interventions

Liposomal Amikacin for Inhalation DRUG

Administered via the Pari LC STAR™ nebulizer.

Also known as: Amikacin Liposome Inhalation Suspension (ALIS),, Arikayce™

Amikacin Liposome Inhalation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

MeSH Terms

Interventions

Inhalation

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: June 2, 2004
• Primary Completion: June 29, 2004
• Study Completion: June 29, 2004
• Last Updated: August 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share