Safety, Tolerability, and Exploratory Efficacy of AGP100 in Patients With Catecholaminergic Polym… (NCT07263139) | Clinical Trial Compass
RecruitingPhase 2
Safety, Tolerability, and Exploratory Efficacy of AGP100 in Patients With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Norway10 participantsStarted 2026-01-02
Plain-language summary
This trial is conducted in patients with an inherited heart rhythm disorder called catecholaminergic polymorphic ventricular tachycardia (CPVT). This condition causes the heart to beat dangerously fast during situations of physical or emotional stress. CPVT is a serious condition that can limit the length and quality of patients' lives. Current treatment does not always prevent the abnormal heart rhythms that can occur as part of CPVT during strenuous exercise or stress, so new and improved medications are needed.
The main questions that the trial will answer are:
* How safe and tolerable is the drug AGP100; i.e, what medical problems do patients experience when taking the drug?
* Does the drug help CPVT patients to maintain a normal heart rhythm while they are exercising?
* How does the drug affect the levels of key heart cell signalling molecules?
Patients with a diagnosis of CPVT who are aged between 18 and 75 and experience abnormal heart rhythms during exercise, despite taking a stable dose of the medication(s) prescribed by their doctor for their CPVT can take part in this trial. Participants should have normal kidney and liver function and not have high blood pressure or a diagnosis of structural heart disease. Women who are pregnant or breastfeeding cannot take part in the study. Participants who may become pregnant (and their partners) need to use highly effective methods of contraception during the study and for 90 days after the study ends.
Participants will take part in the study for ten weeks. During this time, participants will be asked to take three different doses of the the drug (AGP100), as well as their normal heart medication. The drug is an oral capsule and each different dose will be taken once a day for 13 days. The study starts with participants taking a low dose for 2 weeks, then a medium dose and then a high dose. At each dose, participants will undergo a clinical examination, report any potential side effects and the treating doctor will investigate the safety, tolerability and side effects of AGP100. In total, participants will take AGP100 once a day for about six weeks. The last four weeks of the study will be a follow-up period where participants will not take AGP100.
During the study, participants will need to visit the hospital six times. The visits will be three outpatient appointments and three overnight stays.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (AEs)
Timeframe: From Day 1 (start of treatment) through Day 68 [EoS])
2
Changes in heart rate (HR)
Timeframe: Day 1, Day 2, Day 14, Day 15, Day 27, Day 28, Day 39 (End of Treatment), and Day 68 (EoS)
3
Changes in 12-lead electrocardiogram parameters: estimated ventricular frequency
Timeframe: Day 1, Day 2, Day 14, Day 15, Day 27, Day 28, Day 39 (End of Treatment), and Day 68 (EoS)
4
Changes in 12-lead electrocardiogram parameters: PR
Timeframe: Day 1, Day 2, Day 14, Day 15, Day 27, Day 28, Day 39 (End of Treatment), and Day 68 (EoS)
5
Changes in 12-lead electrocardiogram parameters: QRS
Timeframe: Day 1, Day 2, Day 14, Day 15, Day 27, Day 28, Day 39 (End of Treatment), and Day 68 (EoS)
6
Changes in 12-lead electrocardiogram parameters: QTc
Timeframe: Day 1, Day 2, Day 14, Day 15, Day 27, Day 28, Day 39 (End of Treatment), and Day 68 (EoS)
. Clinical laboratory evaluations including clinical chemistry, haematology, urinalysis, thyroid function (including thyroid stimulating hormone, triiodothyronine, thyroxine, and free T4) and coagulation testing (activated partial thromboplastin time, and international normalized ratio) 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) 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 guidelines).
Exclusion criteria
. Diagnosis of structural heart disease, including coronary artery disease or heart failure with reduced ejection fraction (left ventricular ejection fraction \<45%)
. Participants who have had arrhythmias causing hemodynamic instability at previous exercise tests (performed while on the current standard of care treatment)
. 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.
Tolerability of the IMP
Timeframe: From Day 1 (start of treatment) through Day 68 [EoS])