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NCT02720354 Clinical Trial

A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"

Coronary Artery Disease Clinical Trial

Official title:
A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02720354
Other study ID # SK-DMDPA-001
Secondary ID
Status Completed
Phase Phase 1
First received March 15, 2016
Last updated October 18, 2017
Start date May 2016
Est. completion date May 2017

Study information
Verified date November 2016
Source Synektik S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date May 2017
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• [11C]-DMDPA

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Synektik S.A. European Commission

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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