Heart Failure Clinical Trial

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

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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)

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Eligibility Criteria

Cohort 1 Inclusion:

Healthy, age 18-40

Cohort 1 Exclusion:

Significant or chronic medical illness
Pregnant females
Smoking within one month of enrollment
Use of any prescription drugs within 4 weeks prior to dosing

Cohort 2 Inclusion:

30-70 year old subjects with a diagnosis of NYHA Class II-III heart failure
Ejection fraction less than or equal to 35%
Rest SPECT imaging within 90 days prior to enrollment

Cohort 2 Exclusion:

Significant or chronic medical illness
Pregnant females
Known history of arrhythmogenic disorder or rhythm disorder

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT00891241

Recruitment Status:

Completed

Sponsor:

Lantheus Medical Imaging

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There are 2 Locations for this study

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Hartford Hospital
Hartford Connecticut, 06102, United States
Yale University Medical Center
New Haven Connecticut, 06250, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT00891241

Recruitment Status:

Completed

Sponsor:


Lantheus Medical Imaging

How clear is this clinincal trial information?

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