NCT02720354CompletedPhase 1
A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"
Synektik S.A.0 sites12 target enrollmentStarted: May 1, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Primary Endpoint
- 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).
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •body mass index (BMI) between 18.0 and 30.0 kg/m2
- •good health
- •written informed consent
Exclusion Criteria
- •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
Arms & Interventions
A single Intravenous bolus injection
Experimental
A single Intravenous bolus injection of 11C[DMDPA]
Intervention: [11C]-DMDPA (Other)
Outcomes
Primary Outcomes
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).
Time Frame: within 80 minutes
Secondary Outcomes
No secondary outcomes reported
Investigators
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