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

Lantheus Medical Imaging

Status and phase: Completed; Phase 1

Conditions: Heart Failure

Treatments: Drug: LMI 1195-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT00891241

LMI 1195 -101

Details and patient eligibility

About

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)

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Healthy Population

Treatment:

Drug: LMI 1195-101

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: LMI 1195-101