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A Phase 2a Trial to Investigate Safety, Tolerability and Exploratory Efficacy of AGP100 in Patients with Catecholaminergic Polymorphic Ventricular Tachycardia
EU CTIS ID: 2025-521611-39-00
What this study is testing
To assess safety and tolerability of increasing doses of AGP100 in patients with genetically confirmed CPVT and residual ventricular ectopy at exercise testing at stable doses of current standard of care.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent prior to any study-related procedures
- Male or female, aged between 18 and 75 years (inclusive)
- Clinical diagnosis of CPVT based on proven RYR2 mutation AND reproducible premature ventricular contraction with exercise or polymorphic or bidirectional ventricular tachycardia with exercise
- Able and willing to undergo exercise testing (bicycle test) AND exhibits exercise-induced ventricular ectopic beats at Screening (at least 1 point on the VA scale)
- On stable, maximum tolerated, dose of non-selective β-blocker for at least 4 weeks before Visit 1. The dosage and choice of β-blocker are to be determined by the patients’ physician(s) before entry into the study and must remain unchanged throughout the conduct of the study. Participants taking a stable dose of flecainide for at least 4 weeks, in addition to β-blocker, are also eligible. If the patient is taking a daily dose of the non-selective β-blocker nadolol, this must be taken in the evening.
- Clinical laboratory evaluations including clinical chemistry, haematology, urinalysis, thyroid function (including thyroid stimulating hormone [TSH], triiodothyronine [T3], thyroxine [T4], and free T4) and coagulation testing (activated partial thromboplastin time [aPTT], and international normalized ratio [INR]) within the reference range, unless deemed not clinically significant by the Investigator
You likely can't join if
- Diagnosis of structural heart disease, including coronary artery disease or heart failure with reduced ejection fraction (left ventricular ejection fraction < 45%)
- Significant hypertension (defined as systolic blood pressure of >160 mmHg and/or diastolic blood pressure of >95 mmHg). If the blood pressure results are out of range at Screening, the measurements can be repeated on the same day more than once, or at another convenient visit
- Prolonged PR and/or QTc interval at Screening, defined as PR >240 ms or QTc >480 ms
- Positive pregnancy test at Screening or Baseline
- Female participants who are nursing
- WOCBP potential who do not fulfil the criteria as defined in inclusion criterion 8
See the full eligibility criteria
Who can join
- Signed informed consent prior to any study-related procedures
- Male or female, aged between 18 and 75 years (inclusive)
- Clinical diagnosis of CPVT based on proven RYR2 mutation AND reproducible premature ventricular contraction with exercise or polymorphic or bidirectional ventricular tachycardia with exercise
- Able and willing to undergo exercise testing (bicycle test) AND exhibits exercise-induced ventricular ectopic beats at Screening (at least 1 point on the VA scale)
- On stable, maximum tolerated, dose of non-selective β-blocker for at least 4 weeks before Visit 1. The dosage and choice of β-blocker are to be determined by the patients’ physician(s) before entry into the study and must remain unchanged throughout the conduct of the study. Participants taking a stable dose of flecainide for at least 4 weeks, in addition to β-blocker, are also eligible. If the patient is taking a daily dose of the non-selective β-blocker nadolol, this must be taken in the evening.
- Clinical laboratory evaluations including clinical chemistry, haematology, urinalysis, thyroid function (including thyroid stimulating hormone [TSH], triiodothyronine [T3], thyroxine [T4], and free T4) and coagulation testing (activated partial thromboplastin time [aPTT], and international normalized ratio [INR]) within the reference range, unless deemed not clinically significant by the Investigator
- Willing to refrain from strenuous or new exercise for 24 hours before each study visit
- Women of childbearing potential (WOCBP 1) agree to implement accepted and highly effective means of contraception from study entry until at least 33 days after study drug discontinuation (as per the Clinical Trials Facilitation and Coordination Group [CTFG] guidelines). Highly effective methods of birth control are defined as those that achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); intrauterine devices (IUDs); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; sexual abstinence; vasectomised partner. 1 A woman is considered of childbearing potential, i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Procedures must have been completed at least 6 months prior to Baseline. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
What rules you out
- Diagnosis of structural heart disease, including coronary artery disease or heart failure with reduced ejection fraction (left ventricular ejection fraction < 45%)
- Significant hypertension (defined as systolic blood pressure of >160 mmHg and/or diastolic blood pressure of >95 mmHg). If the blood pressure results are out of range at Screening, the measurements can be repeated on the same day more than once, or at another convenient visit
- Prolonged PR and/or QTc interval at Screening, defined as PR >240 ms or QTc >480 ms
- Positive pregnancy test at Screening or Baseline
- Female participants who are nursing
- WOCBP potential who do not fulfil the criteria as defined in inclusion criterion 8
- Known active infection or major haematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction, as judged by the Investigator at Baseline
- Severe renal impairment (e.g., estimated glomerular filtration rate <30 mL/min at Screening) or severe hepatic impairment (ASAT, ALAT, ALP or GGT > 2.5 times upper limit of normal (ULN) or bilirubin >1.5 times ULN at Screening)
- Current or recent (within 3 months of Baseline) gastrointestinal disease
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the IMP
- Regular use of anticoagulants or platelet inhibitors (including aspirin)
- Participants who have had arrhythmias causing hemodynamic instability at previous exercise tests (performed while on the current standard of care treatment)
- Use of any medications, or dietary or herbal supplements, prescription or available over the counter, which are known to chronically alter drug absorption or elimination processes, known to induce or inhibit CYP3A4 or CYP2B6 are contraindicated for treatment with PDE2 inhibitors within 30 days or 5 half-lives (whichever is longer) of Baseline. See Appendix B for Prohibited Medication.
- Ingestion of grapefruit-containing foods or beverages in the 14 days prior to Baseline.
- Plasma donation in the 28 days prior to Baseline or blood donation or equivalent blood loss in the 3 months prior to Baseline
- Diagnosis of cancer in the 5 years prior to Baseline, with the exception of basal cell or squamous cell carcinoma of the skin that has been cured or cervical carcinoma in situ that has been cured
- History of major psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder, personality disorder) within 12 months prior to Screening
- History of drug abuse or excessive alcohol use within 12 months prior to Screening
- Participants who, in the opinion of the investigator, are not suitable candidates for the study
- Participants who are judged unable to comply with the requirements of the study as judged by the Investigator
- Participants under judicial supervision, guardianship, or curatorship
- Participants having a sustained VT (VA score of 5) during the exercise tests performed as part of the screening activities
- Participation in another clinical study with an investigational product or device within 60 days of 5 half-lives prior to Baseline (whichever is longer)
- Medical history of severe anaphylactic reactions to any component(s) of the IMP
- Sensitivity to any of the study treatments, or components thereof, or any drug or other allergy that, in the opinion of the Investigator, precludes participation in the study
- Hypersensitivity or contraindication to PDE2 inhibitor drugs
- Use of PDE3, PDE4, or PDE5 inhibitor drugs. See Appendix B for Prohibited Medication
- Participants taking any antiarrhythmic drug(s) except flecainide and non-selective β-blockers
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.