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

This study has been completed.
Sponsor:
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00891241
First received: April 29, 2009
Last updated: August 17, 2011
Last verified: August 2011
  Purpose

The purpose of this clinical study is to estimate the radiation dosimetry of a single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron emission tomography (PET)


Condition Intervention Phase
Heart Failure
Drug: LMI 1195-101
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Multi-Center, Single Dose, Phase I, Dosimetry, Biodistribution, and Safety Trial of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • Safety [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Safety will be assessed by monitoring AEs, clinical laboratory tests, cardiac enzymes, ECGs, physical examinations and vital signs


Secondary Outcome Measures:
  • Dosimetry [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: August 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Healthy Population
Drug: LMI 1195-101
Single dose, bolus IV injection of LMI 1195
Other Name: 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 Name: LMI 1195-101 Clinical Trial

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891241

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Yale University Medical Center
New Haven, Connecticut, United States, 06250
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: L. Veronica Lee, M.D. Medical Monitor - Lantheus Medical Imaging
  More Information

No publications provided

Responsible Party: Veronica Lee M.D., Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00891241     History of Changes
Other Study ID Numbers: LMI 1195 -101
Study First Received: April 29, 2009
Last Updated: August 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:
Heart Failure, PET Imaging, Implantable Cardioverter-Defibrillator, Dosimetry

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014