Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (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 Outcomes (4)

Percent Dose Deposited in Oropharyngeal and Stomach Region
At multiple timepoints post-administration up to Day 2
Percent Dose Remaining in the Device Including the Mouthpiece
At multiple timepoints post-administration up to Day 2
Percent Dose Remaining in the Low Resistance Exhalation Filter
At multiple timepoints post-administration up to Day 2
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

Study Arms (1)

Amikacin Liposome Inhalation

EXPERIMENTAL

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

Drug: Liposomal Amikacin for Inhalation

Interventions

Liposomal Amikacin for InhalationDrug

Administered via the Pari LC STAR™ nebulizer.

Also known as: Amikacin Liposome Inhalation Suspension (ALIS),, Arikayce™

Amikacin Liposome Inhalation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Liposomal Amikacin for Inhalation
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry record

Eligibility Criteria

Age18 Years - 50 Years

Sexmale(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Participants with a body mass index (BMI) of 20-28.
Participants with negative human immunodeficiency virus (HIV) and Hepatitis B and C results.

Sponsors & Collaborators

Insmed Incorporated
Industrylead

MeSH Terms

Interventions

Inhalation

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 11, 2023

First Posted

August 21, 2023

Study Start

June 2, 2004

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Amikacin Liposome Inhalation

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Amikacin Liposome Inhalation

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record