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

November 12, 2020 updated by: Lantheus Medical Imaging

A Multi-Center, Single Dose, Phase I, Dosimetry, Biodistribution, and Safety Trial of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort 1
Healthy Population
Drug: LMI 1195-101
Single dose, bolus IV injection of LMI 1195
Other Names:
  • LMI 1195-101 Clinical Trial
EXPERIMENTAL: 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
Drug: LMI 1195-101
Single dose, bolus IV injection of LMI 1195
Other Names:
  • LMI 1195-101 Clinical Trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of LMI 1195 in terms of treatment-related adverse events
Time Frame: 14 days
Number of study subjects exhibiting treatment-related adverse events
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Dosimetry of a single dose of LMI 1195
Time Frame: 2 days
Radiation dose to organs defined by the MIRD model, in mGy/MBq
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lantheus Medical Imaging

Investigators

  • Study Director: L. Veronica Lee, M.D., Medical Monitor - Lantheus Medical Imaging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

April 29, 2009

First Submitted That Met QC Criteria

April 30, 2009

First Posted (ESTIMATE)

May 1, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMI 1195 -101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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