Clinical Trials Register

Summary
EudraCT Number:	2017-002055-28
Sponsor's Protocol Code Number:	SK-DMDPA-02
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-08-23
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2017-002055-28

A.3

Full title of the trial

Safety and dose optimization for [11C] DMDPA as a PET imaging agent for evaluation of myocardial perfusion in subjects with known or suspected coronary artery disease (CAD).

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Evaluation of [11C] DMDPA product during coronary artery disease diagnostic with positron emission tomography (PET)

A.4.1

Sponsor's protocol code number

SK-DMDPA-02

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Synektik Spółka Akcyjna
B.1.3.4	Country	Poland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Synektik Spółka Akcyjna
B.4.2	Country	Poland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ClinMed Pharma Sp. z o.o.
B.5.2	Functional name of contact point	CRO company
B.5.3	Address:
B.5.3.1	Street Address	Erazma Ciołka 12
B.5.3.2	Town/ city	Warszawa
B.5.3.3	Post code	01-402
B.5.3.4	Country	Poland
B.5.4	Telephone number	+48601887786
B.5.5	Fax number	+4822379 64 50
B.5.6	E-mail	wkula@clinmed.pl

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	[11C]-DMDPA
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	[11C] dimethyl diphenyl ammonium chloride ([11C]-DMDPA)
D.3.9.2	Current sponsor code	[11C] DMDPA
D.3.9.3	Other descriptive name	[11C] DIMETHYL DIPHENYL AMMONIUM
D.3.9.4	EV Substance Code	SUB188871
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1100 ± 15% MBq
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	Yes
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	[11C]-DMDPA
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	[11C]‐dimethyl‐diphenyl ammonium chloride ([11C]-DMDPA)
D.3.9.2	Current sponsor code	[11C] DMDPA
D.3.9.3	Other descriptive name	[11C]‐DIMETHYL‐DIPHENYL AMMONIUM
D.3.9.4	EV Substance Code	SUB188871
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	740 ± 15% MBq
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	Yes
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	[11C]-DMDPA
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	[11C] dimethyl diphenyl ammonium chloride ([11C]-DMDPA)
D.3.9.2	Current sponsor code	[11C] DMDPA
D.3.9.3	Other descriptive name	[11C] DIMETHYL DIPHENYL AMMONIUM
D.3.9.4	EV Substance Code	SUB188871
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	370± 15% MBq
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	Yes
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

known or suspected coronary artery disease

E.1.1.1

Medical condition in easily understood language

known or suspected coronary artery disease

rozpoznana lub podejrzana choroba wieńcowa

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10011078
E.1.2	Term	Coronary artery disease
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess safety of [11C] DMDPA used as PET imaging agent for evaluation of myocardial perfusion in subjects with known or suspected CAD.
To optimize the [11C] DMDPA dose used for PET evaluation of myocardial perfusion in subjects with known or suspected CAD at vasodilatation stress and at rest.

E.2.2

Secondary objectives of the trial

To optimize the imaging parameters for dynamic and static acquisitions.
To evaluate diagnostic ability to detect fixed and reversible perfusion abnormalities.
To define its ability to measure myocardial perfusion with regard to image quality, certainty of interpretation, and feasibility of measurement.
To define its ability to measure myocardial perfusion with regard to interpretation confidence in patients with suspected or proven CAD.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Male and female subjects over 18 years of age with known (proven myocardial infarction or one or more significant narrowing in coronary angiography) or suspected CAD having given informed consent referred for MPI for diagnosis and/or risk stratification for CAD
or
Patients after ICA without PCI within 60 days.

E.4

Principal exclusion criteria

Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
Blood pressure over 180/100 mmHg or below 100 mmHg systolic
Acute changes in comparison to most recent electrocardiogram (ECG);
Recent (within 3 months) cardiac arrest, unstable angina, cerebro vascular accident (CVA), coronary artery bypass grafting (CABG) or PCI
Any pacemaker or defibrillator implanted within the last three months;
Inability to remain in camera for approximately 15 minutes
Bronchospasm
Serum creatinine > 2 mg/dL;
Cancer patients who have received chemotherapy or radiation therapy or antiangiogenic within the past 60 days.
Any exposure to any investigational drug(s) or medical device(s) within four weeks prior to imaging study;
Any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination.
NYHA Class III or IV Congestive heart failure;
Subject has symptomatic hypotension
Allergic or intolerant to theophylline, nitroglycerin or metoprolol
Female subjects only: Positive serum and/or urine pregnancy test or is lactating or the possibility of pregnancy cannot be ruled out prior to dosing. Females of child-bearing potential (defined as all females after puberty who are not postmenopausal for at least 1 year, or who undergo hysterectomy or who are surgically sterile e.g. after ovariectomy or bilateral tubal ligation) require confirmatory documentation in their medical records and must have a negative pregnancy test within 4 hours prior to receiving the test drug and agree to use an acceptable form of birth control for at least 30 days before V1 and at least 30 days following [11C]-DMDPA injection;
Adequate contraceptive measures include: oral contraceptives, contraceptive injections or implants, hormone patches (stable use for 1 or more cycles before V1); intrauterine device; condom or diaphragm with spermicide; or sexual abstinence.
Contraceptive methods that are not adequate and not acceptable during the study are: periodic sexual abstinence assessed based on e.g. ovulation calendar, fertility days by monitoring of temperature and / or symptom observation (cervical mucus, mood changes);
Sexually active female of child bearing potential must agree to use two adequate contraceptive methods e.g. condom and oral contraceptive. Note: it is not acceptable to use condom and diaphragm simultaneously because during sexual act the devices can be damaged and do not prevent pregnancy.

Nursing mothers
Male subjects would require reliable contraception method from the first injection with the tracer until 100 days after the last injection with the tracer.
The following contraceptive method(s) is (are) allowed during the study: Condom or sexual abstinence.
If the partner becomes pregnant during the study, the participant should immediately report this to the investigator.
Presence of absolute contraindications to the procedure
hypersensitivity to the radiopharmaceutical
second degree A-V block in the patient without cardiostimulator
inability to lie still for the duration of the acquisition
claustrophobia
Presence of relative contraindications to the procedure
Xanthine derivatives (caffeine, theophylline, and theobromine containing foods and beverages, and theophylline, caffeinecontaining medications) within 12 hours before the imaging (stress imaging with vasodilators). .

E.5 End points

E.5.1

Primary end point(s)

1.Safety: the number and proportion of related adverse events (AEs) per study (dose) arm;
2.Dose finding: the number and proportion of patients in whom calculated perfusion is within 0.5 5 mL/g tissue/minute per study (dose) arm.

E.5.1.1

Timepoint(s) of evaluation of this end point

1.V1, V2, V3, V4
2.Randomization (V1)

E.5.2

Secondary end point(s)

1.To assess sensitivity and specificity for each [11C] DMDPA dose arm for the detection of perfusion disturbances.
2.To assess the number and proportion of patients with interpretable images per study (dose) arm as assessed by blinded evaluators.
3.To compare baseline (pre-injection) values to post-injection values for:
• Laboratory testing which includes hematology, serum chemistry, urine analysis, and cardiovascular markers
• Electrocardiograms, Serial QT and QTc measurements
• Physical Examinations
• Vital signs which includes heart rate, and systolic and diastolic blood pressure
• AE Assessments

E.5.2.1

Timepoint(s) of evaluation of this end point

1.Randomization (V1)
2.Randomization (V1)
3.a)Randomization (V1) versus V2
b) V0,V1, V2, V3, V4
c) V0,V1, V2, V3, V4
d) V0,V1, V2, V3, V4
e) V0,V1, V2, V3, V4

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Since the study has only a diagnostic objective, patients who complete the study will continue their treatment with their specialist physician.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-10-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-07-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-04-05

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials