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Phase 2a Study of AGP100 Safety, Tolerability, and Early Effectiveness 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
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 visitsthree 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)
Research Team
R
Rizwan Hussain, MD PhD
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