Status:
COMPLETED
A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants
Lead Sponsor:
Insmed Incorporated
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 2 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2004
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05999942
Start Date
June 2 2004
End Date
June 29 2004
Last Update
August 21 2023
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