A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Terrence Ruddy, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01558362
First received: March 7, 2012
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

The need exists for alternatives to 99mTc based perfusion radiotracers for cardiac patient management. An alternative radiotracer, I123-CMICE-013, has been developed at the Canadian Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute. Initial testing results in rats and pigs suggest that in addition to being a cyclotron-produced alternative to 99mTc tracers, I-123-CMICE-013 may be a superior tracer for measuring myocardial perfusion.This Phase 1 study will study the safety and tolerability, biodistribution, pharmacokinetics and radiation dosimetry, and distribution and localization of I123-CMICE-013in healthy adult volunteers.


Condition Intervention Phase
Coronary Artery Disease
Drug: 123I-CMICE-013
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase 1 Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 123I-CMICE-013 Administered Intravenously in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • Biodistribution [ Time Frame: 0 to 24 hours post injection ] [ Designated as safety issue: No ]

    Quantitative in vivo biodistribution will be determined through whole-body planar imaging immediately and at 90 mins, 4 hrs, 6 hrs and 24 hrs post injection. Venous blood samples of 10 ml volume each will be taken at nominal times of 5, 10, 15, 30, 60, 90 and 180 minutes post administration and at 6 and 24 hours and activity measured. Urine and faeces as voided up to 24 hrs post administration will be assayed.

    Internal radiation dose, Effective Dose Equivalent (ICRP 30), Effective Dose (ICRP 60) and organ residence times will be calculated.



Secondary Outcome Measures:
  • Safety/Tolerability [ Time Frame: 0 to 7 days post injection ] [ Designated as safety issue: Yes ]
    Adverse events and Serious Adverse Events will be recorded and reported.


Estimated Enrollment: 12
Study Start Date: April 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 123I-CMICE-013
Administration and analysis of alternative MPI radiotracer
Drug: 123I-CMICE-013
2 intravenous doses of drug will be given one week apart. Doses will be equivalent to 1 rest dose and 1 stress dose. Serial nuclear imaging will follow dose injections.

Detailed Description:

Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is an established, cost effective tool for the risk stratification and management of patients suspected or known to have coronary artery disease (CAD)Myocardial perfusion imaging is significantly affected by interruptions in the supply of 99mMo, the parent isotope of 99mTc used for the majority of MPI. An alternative radiotracer, I123-CMICE-013,developed at the Canadian Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute, has completed pre-clinical trial testing and is ready for Phase 1 human trials.

This Phase I study will be a single centre, open label study. Subjects will receive 2 doses of study drug. One rest dose and one stress dose will be administered on separate days, one week apart. Subjects will undergo a standard clinical exercise stress protocol for the stress dose. Gamma camera imaging following each administration will be done over 2 days.

Biodistribution, pharmacokinetics, dosimetry and safety variables will be analyzed.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 18 and 65 years
  2. No significant medical history
  3. Normal physical exam
  4. BMI ≤ 30 kg/m2
  5. No current use of prescription medication
  6. No clinically significant abnormalities in baseline laboratory work
  7. No clinically significant abnormalities in baseline 12 lead electrocardiogram
  8. Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening

Exclusion Criteria:

  1. Pregnancy
  2. Known hypersensitivity to the investigational drug or any of its components
  3. Claustrophobia or inability to lie still in a supine position
  4. Unwillingness to provide informed consent
  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: NCT01558362

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Terrence D Ruddy, MD Ottawa Heart Institute Research Corporation
  More Information

No publications provided

Responsible Party: Terrence Ruddy, Principal Investigator, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01558362     History of Changes
Other Study ID Numbers: 20120080-01H
Study First Received: March 7, 2012
Last Updated: March 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Heart Institute Research Corporation:
myocardial perfusion imaging
single photon emission tomography
Coronary artery disease
gamma camera imaging
Phase 1 clinical trial
cyclotron

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 02, 2014