Actively Recruiting
Safety, Tolerability, and Exploratory Clinical Efficacy of AGP100 in Adults With Catecholaminergic Polymorphic Ventricular Tachycardia
Led by Agiana Pharmaceuticals · Updated on 2025-12-26
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Agiana Pharmaceuticals
Lead Sponsor
L
Link Medical Research AS
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating AGP100, an investigational drug, in adults aged 18 to 75 with catecholaminergic polymorphic ventricular tachycardia (CPVT), a serious inherited heart rhythm disorder causing dangerously fast heartbeats during physical or emotional stress. The study aims to assess the safety, tolerability, and preliminary effectiveness of AGP100 in helping maintain normal heart rhythm during exercise, as current treatments do not always prevent abnormal rhythms in CPVT patients. This phase IIa trial is sponsored by Agiana Pharmaceuticals and is the first trial of AGP100 in CPVT patients rather than healthy volunteers. Participants will receive three escalating oral doses of AGP100: 5 mg, 25 mg, and 50 mg once daily for about 13 days each, alongside their current heart medications. The study uses an intra-patient dose escalation design where each participant serves as their own control. The treatment period lasts about six weeks, followed by a four-week follow-up without AGP100. Each dose period includes supervised dosing and exercise testing to monitor safety and heart rhythm effects, with blood samples and continuous ECG monitoring during overnight hospital stays. Participants will be involved for a total of 68 days, including six hospital visits—three outpatient visits and three overnight stays. They will undergo clinical exams, exercise tests, blood sampling, and 24-hour ECG monitoring to track heart rate, electrocardiogram changes, and heart cell signaling molecules. Participants will report daily medication use through an electronic system. The main outcomes include safety evaluations, heart rhythm measurements during exercise, and tolerability of AGP100. The study will provide key data to inform future development of this new antiarrhythmic therapy.
CONDITIONS
Brief Title
Safety, Tolerability, and Exploratory Efficacy of AGP100 in Patients With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Male or female aged 18 to 75 years
- Diagnosed with CPVT confirmed by RYR2 mutation and exercise-induced abnormal heart rhythms
- Able and willing to undergo bicycle exercise testing showing exercise-induced ventricular ectopic beats
- On a stable, maximum tolerated dose of non-selective beta-blocker for at least 4 weeks before study start
- Stable dose of flecainide allowed if taken with beta-blockers for at least 4 weeks
- Normal clinical lab tests including chemistry, blood counts, thyroid, and coagulation within reference ranges
- Willing to avoid strenuous or new exercise for 24 hours before each study visit
- Women able to become pregnant must use highly effective contraception during the study and 33 days after stopping the drug
You will not qualify if you...
- Diagnosis of structural heart disease including coronary artery disease or heart failure with reduced ejection fraction (<45%)
- History of arrhythmias causing instability during prior exercise tests
- Sustained ventricular tachycardia during screening exercise tests
- Participation in another investigational study within 60 days or 5 half-lives before baseline
- History of severe allergic reactions to study drug components
- Sensitivity or allergy to study treatments or any drug that prevents safe participation
- Hypersensitivity or contraindication to PDE2 inhibitor drugs
- Use of PDE3, PDE4, or PDE5 inhibitor drugs
- Use of antiarrhythmic drugs other than flecainide and non-selective beta-blockers
- Significant high blood pressure (systolic >160 mmHg or diastolic >95 mmHg)
- Prolonged PR interval >240 ms or QTc interval >480 ms at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Approximately 6 weeks (three 2-week treatment periods)
Participants receive ascending doses of AGP100 alongside their standard of care medication in three sequential 2-week treatment periods. Each period includes in-person dosing, exercise testing, blood sampling, and 24-hour ECG monitoring at the study site, with daily self-administration of the medication at home between visits.
4 overnight visits at the study site and outpatient visits on the last treatment day; daily self-administration of medication at home
Duration - 4 weeks
Participants enter a 4-week follow-up period without study treatment, during which safety and efficacy are monitored, including a final exercise test at the end of the study.
Final outpatient visit with exercise testing
Trial Site Locations
Total: 1 location
1
Department of Cardiology, Oslo University Hospital
Oslo, Norway
Actively Recruiting
Research Team
R
Rizwan Hussain, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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