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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Radiopharmaceuticals

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