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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05999942
• Other study ID #: RD 201/23924
• Status: Completed
• Phase: Phase 1
• Start date: June 2, 2004
• Est. completion date: June 29, 2004

Study information

• Verified date: July 2023
• Source: Insmed Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 29, 2004
• Est. primary completion date: June 29, 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Liposomal Amikacin for Inhalation
Administered via the Pari LC STAR™ nebulizer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Insmed Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent Dose Deposited in Oropharyngeal and Stomach Region		At multiple timepoints post-administration up to Day 2
Secondary	Percent Dose Remaining in the Device Including the Mouthpiece		At multiple timepoints post-administration up to Day 2
Secondary	Percent Dose Remaining in the Low Resistance Exhalation Filter		At multiple timepoints post-administration up to Day 2
Secondary	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