A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
NCT ID: NCT00891241
Last Updated: 2020-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2009-08-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort 1
Healthy Population
LMI 1195-101
Single dose, bolus IV injection of LMI 1195
Cohort 2
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
LMI 1195-101
Single dose, bolus IV injection of LMI 1195
Interventions
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LMI 1195-101
Single dose, bolus IV injection of LMI 1195
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
18 Years
70 Years
ALL
Yes
Sponsors
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Lantheus Medical Imaging
INDUSTRY
Responsible Party
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Principal Investigators
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L. Veronica Lee, M.D.
Role: STUDY_DIRECTOR
Medical Monitor - Lantheus Medical Imaging
Locations
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Hartford Hospital
Hartford, Connecticut, United States
Yale University Medical Center
New Haven, Connecticut, United States
Countries
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Other Identifiers
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LMI 1195 -101
Identifier Type: -
Identifier Source: org_study_id