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

Synektik

Status and phase: Completed; Phase 1

Conditions: Coronary Artery Disease

Treatments: Other: [11C]-DMDPA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02720354

SK-DMDPA-001

Details and patient eligibility

About

[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

Enrollment: 12 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

A single Intravenous bolus injection

Experimental group

Description:

A single Intravenous bolus injection of 11C\[DMDPA\]

Treatment:

Other: [11C]-DMDPA