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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lantheus Medical Imaging

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