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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1 Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 123I-CMICE-013 Administered Intravenously in Healthy Adult Volunteers

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: 123I-CMICE-013


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years No significant medical history Normal physical exam BMI ≤ 30 kg/m2 No current use of prescription medication No clinically significant abnormalities in baseline laboratory work No clinically significant abnormalities in baseline 12 lead electrocardiogram Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening Exclusion Criteria: Pregnancy Known hypersensitivity to the investigational drug or any of its components Claustrophobia or inability to lie still in a supine position Unwillingness to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 123I-CMICE-013<br>Administration and analysis of alternative MPI radiotracer | Drug: 123I-CMICE-013<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biodistribution | 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. | 0 to 24 hours post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/Tolerability | Adverse events and Serious Adverse Events will be recorded and reported. | 0 to 7 days post injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial perfusion imaging, single photon emission tomography, Coronary artery disease, gamma camera imaging, Phase 1 clinical trial, cyclotron