A Phase I Study of a Novel Tracer for Positron Emission T... | NCT02720354

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

NCT02720354

Sponsor

Synektik S.A.

Status

Completed

Last Update Posted

Oct 20, 2017Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Coronary Artery Disease

Interventions

[11C]-DMDPA

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Feb 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Mar 15, 2016

First Submission Date that Met QC Criteria

Mar 21, 2016

First Posted Date

Mar 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2017

Last Update Posted Date

Oct 20, 2017Actual

Name	Class
European Commission	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A single Intravenous bolus injection	Experimental	A single Intravenous bolus injection of 11C[DMDPA]	Other: [11C]-DMDPA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[11C]-DMDPA	Other		A single Intravenous bolus injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided