Status:
COMPLETED
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
Lead Sponsor:
Lantheus Medical Imaging
Conditions:
Heart Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00891241
Start Date
August 1 2009
End Date
November 1 2009
Last Update
November 16 2020
Active Locations (2)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06102
2
Yale University Medical Center
New Haven, Connecticut, United States, 06250