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Completed

NCT Number: NCT00891241

A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety 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)

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hartford Hospital, Hartford, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LMI 1195-101

Drug

Single dose, bolus IV injection of LMI 1195

Other names: LMI 1195-101 Clinical Trial

Primary outcomes

  1. Safety of LMI 1195 in terms of treatment-related adverse events

    Time frame: 14 days

    Number of study subjects exhibiting treatment-related adverse events

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Lantheus Medical Imaging

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 1, 2009
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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