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

March 7, 2012
March 5, 2014
April 2012
March 2014   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01558362 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers
A Phase 1 Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 123I-CMICE-013 Administered Intravenously in Healthy Adult Volunteers

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
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.
Experimental: 123I-CMICE-013
Administration and analysis of alternative MPI radiotracer
Intervention: Drug: 123I-CMICE-013
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
March 2015
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01558362
20120080-01H
No
Terrence Ruddy, University of Ottawa Heart Institute
University of Ottawa Heart Institute
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Terrence D Ruddy, MD University of Ottawa Heart Institute
University of Ottawa Heart Institute
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP