A Phase I/II Seamless Adaptive, Open label study to assess Safety, Tolerability, Radiation Dosimetry, Biodistribution, and diagnostic ability of a Novel 18F-labelled Tracer, SYN2, for Positron Emission Tomography in Myocardial Perfusion Imaging (SAFER) in Healthy Volunteers (phase I) and patients with suspected Coronary Artery Disease (phase II)

Phase 1

• Conditions: phase II: suspected coronary artery disease; MedDRA version: 20.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-003087-43-PL
• Lead Sponsor: Synektik Spólka Akcyjna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-06
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Phase I
Inclusion Criteria
1.Must be willing and able to provide signed written informed consent prior to any study related procedures;
2.Male or Female, over 18 years of age;
3.Body mass index < 30 kg/m2
4.Normal or clinically acceptable medical history, physical examination, ECG, and vital signs findings during the screening period as determined by the investigator.
5.Must have a serum creatinine within the normal limits investigational site's normal range.
6.Must have liver function tests < 1.5 times the investigational site's normal range.
7.Must have a haematocrit level within 5% of the investigational site's normal range.
8.Willingness to abstain sexual intercourse at least 24 hours before and after the tracer administration
9.Willingness to practice effective contraception for 3 months after the tracer administration
10.Negative test results for drugs of abuse and alcohol at screening and on the day of tracer administration/PET imaging

Phase II
Inclusion Criteria:
1.Must be willing and able to provide signed written informed consent prior to any study related procedures;
2.Male or Female, over 18 years of age;
3.At the time of enrolment, the patient has been scheduled via written documentation to undergo an angiography for the assessment of CAD.
4.The patient has undergone a clinically indicated SPECT MPI study within 180 days before informed consenting OR the patient is willing to undergo SPECT MPI study for the purposes of this clinical study.
5.The subject is able and willing to comply with all study procedures as described in the protocol.
6.Willingness to abstain sexual intercourse at least 24 hours before and after the tracer administration
7.Willingness to practice effective contraception for 3 months after the tracer administration

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Phase I:
Exclusion Criteria:
1.Any clinically significant acute or chronic unstable physical or psychological disease based on medical history or screening physical examination;
2.Any clinically significant abnormality in the screening laboratory tests or ECG;
3.Any exposure to any investigational drugs within four (4) weeks prior to Visit 1;
4.Any exposure to investigational radiopharmaceuticals within 12 months prior to the date of Visit 1;
5.Any new prescription medications within four (4) weeks of Visit 1;
6.Subject has a positive (+)pregnancy test, the possibility of pregnancy cannot be ruled out prior to dosing, or the subject is breast-feeding.
7.Subject has experienced any allergic reaction to similar compounds or agents.
8. Subject has a positive SARS-CoV-2 test result on screening.

Phase II:
Exclusion Criteria:
1.Patients who are unable to undergo all the imaging procedures based on the investigators opinion. Reasons may be any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination.
2.Patients who have an established diagnosis of CAD as confirmed by any of the following:
1.Previous myocardial infarction (MI);
2.Previous cardiac catheter angiography showing =50% stenosis;
3.Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement.
3.Patients incapable of undergoing pharmacological cardiac stress testing.
4.Patients who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the patient during cardiac stress testing.
5.Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <50%).
6.Patients scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA (e.g. balloon angioplasty or bypass syrgery).
7.Patients without abnormalities in the SPECT MPI performed at screening visit (V0).
8. Patients undergoing evaluation for heart transplantation or with history of heart transplantation.
9.Patients enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up period of this study
10.Female subject has a positive (+) pregnancy test, the possibility of pregnancy cannot be ruled out prior to dosing, or the subject is breast-feeding.
11. Subject has a positive SARS-CoV-2 test result on screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified