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

Sponsor
Insmed Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT05999942
Collaborator
(none)
6
Enrollment
1
Arm
27
Actual Duration (Days)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Liposomal Amikacin for Inhalation
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Gamma Scintigraphy Study to Investigate the Lung Deposition of Inhaled Amikacin-Loaded Liposomes in Healthy Male Volunteers
Actual Study Start Date :
Jun 2, 2004
Actual Primary Completion Date :
Jun 29, 2004
Actual Study Completion Date :
Jun 29, 2004

Arms and Interventions

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™

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. Percent Dose Deposited in Oropharyngeal and Stomach Region [At multiple timepoints post-administration up to Day 2]

    2. Percent Dose Remaining in the Device Including the Mouthpiece [At multiple timepoints post-administration up to Day 2]

    3. Percent Dose Remaining in the Low Resistance Exhalation Filter [At multiple timepoints post-administration up to Day 2]

    4. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts 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/exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Insmed Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Insmed Incorporated
    ClinicalTrials.gov Identifier:
    NCT05999942
    Other Study ID Numbers:
    • RD 201/23924
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Amikacin

    Study Results

    No Results Posted as of Aug 21, 2023