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

NCT ID: NCT05999942

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-02
• Study Completion Date: 2004-06-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Amikacin Liposome Inhalation

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

Group Type: EXPERIMENTAL

Liposomal Amikacin for Inhalation

Intervention Type: DRUG

Administered via the Pari LC STAR™ nebulizer.

Interventions

Liposomal Amikacin for Inhalation

Administered via the Pari LC STAR™ nebulizer.

Intervention Type: DRUG

Other Intervention Names

Amikacin Liposome Inhalation Suspension (ALIS),; Arikayce™

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Insmed Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RD 201/23924

Identifier Type: -

Identifier Source: org_study_id