A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"
Phase 1
Completed
- Conditions
- Coronary Artery Disease
- Interventions
- Other: [11C]-DMDPA
- Registration Number
- NCT02720354
- Lead Sponsor
- Synektik S.A.
- Brief Summary
\[11C\]-dimethyl-diphenyl ammonium (\[11C\]-DMDPA) - A Phase I, Open-label, Safety and Tolerability, Radiation Dosimetry, Biodistribution, First-in-Human Study of a Novel 11C-labeled Tracer for Positron Emission Tomography Myocardial Perfusion Imaging
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
- body mass index (BMI) between 18.0 and 30.0 kg/m2
- good health
- written informed consent
Exclusion Criteria
- smokers
- subject receiving medication
- a blood transfusion in the 4 weeks prior to screening
- positive alcohol blood test
- Subjects who suffer from claustrophobia
- Subjects who have had a clinically significant illness
- Subjects exposed to radiation within 12 months prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A single Intravenous bolus injection [11C]-DMDPA A single Intravenous bolus injection of 11C\[DMDPA\]
- Primary Outcome Measures
Name Time Method Measurement of absorbed radiation dose for all target organs in megabecquerel (the activity of a quantity of radioactive material in which one nucleus decays per second). within 80 minutes
- Secondary Outcome Measures
Name Time Method