A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure

Phase 1

Completed

• Conditions: Heart Failure
• Interventions: Drug: LMI 1195-101

• Registration Number: NCT00891241
• Lead Sponsor: Lantheus Medical Imaging

Brief Summary

The purpose of this clinical study is to estimate the safety and radiation dosimetry of a single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron emission tomography (PET)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-04-29
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Study Start: 2009-08
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	LMI 1195-101	Healthy Population
Cohort 2	LMI 1195-101	Heart Failure Subjects with a documented ejection fraction of 35% or less, and a diagnosis of NYHA Class II-III heart failure, history of ventricular arrhythmia and ICD placement

Primary Outcome Measures

Name	Time	Method
Safety of LMI 1195 in terms of treatment-related adverse events	14 days	Number of study subjects exhibiting treatment-related adverse events

Secondary Outcome Measures

Name	Time	Method
Radiation Dosimetry of a single dose of LMI 1195	2 days	Radiation dose to organs defined by the MIRD model, in mGy/MBq

Trial Locations

Locations (2)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Yale University Medical Center; 🇺🇸 New Haven, Connecticut, United States