Skip to main content
OpenTrials
Completed

NCT Number: NCT05999942

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liposomal amikacin for inhalation

Drug

Administered via the Pari LC STAR™ nebulizer.

Other names: Amikacin Liposome Inhalation Suspension (ALIS),, Arikayce™

Primary outcomes

  1. Pulmonary Deposition of Radiolabelled Amikacin-loaded Liposomes Measured as Percentage Retention of Emitted Dose Deposited in the Lungs

    Time frame: Pre-administration and 2 hours post-administration on Day 1

Secondary outcomes

  1. Percent Dose Deposited in Oropharyngeal and Stomach Region

    Time frame: At multiple timepoints post-administration up to Day 2

  2. Percent Dose Remaining in the Device Including the Mouthpiece

    Time frame: At multiple timepoints post-administration up to Day 2

  3. Percent Dose Remaining in the Low Resistance Exhalation Filter

    Time frame: 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)

    Time frame: Pre-administration and 2 hours post- administration on Day 1

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study title

A Gamma Scintigraphy Study to Investigate the Lung Deposition of Inhaled Amikacin-Loaded Liposomes in Healthy Male Volunteers

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.