NCT02720354

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 coronary-artery-disease

Timeline
Completed

Started May 2016

Shorter than P25 for phase_1 coronary-artery-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 20, 2017

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

March 15, 2016

Last Update Submit

October 18, 2017

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

A single Intravenous bolus injection

EXPERIMENTAL

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

Other: [11C]-DMDPA

Interventions

[11C]-DMDPAOTHER
A single Intravenous bolus injection

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index (BMI) between 18.0 and 30.0 kg/m2
  • good health
  • written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 25, 2016

Study Start

May 1, 2016

Primary Completion

February 1, 2017

Study Completion

May 1, 2017

Last Updated

October 20, 2017

Record last verified: 2016-11