Dose Escalation Study to Assess Safety, Tolerability, and Efficacy of Budiodarone Treatment With Non-permanent Atrial Fibrillation

Summary

This multicenter, open-label study aims to assess the safety, tolerability and efficacy of budiodarone in treating participants with non-permanent AF, in particular paroxysmal atrial fibrillation (PAF). The trial will serve as a 6-month safety and a proof-of-concept study for a dose escalation strategy using AF monitoring, enrolling approximately 100 participants who will undergo 24 weeks of treatment. The study aims to evaluate the feasibility of dose escalation through AF monitoring of long episodes atrial fibrillation last 5 hours or longer.

Eligibility

Key Inclusion Criteria:

* Proven paroxysmal atrial fibrillation or undergoing first-time elective electrical (direct current) cardioversion for persistent atrial fibrillation, or second-time elective electrical (direct current) cardioversion.
* Baseline AF Criteria: To qualify for treatment, each participant must have during the 28-day baseline period an AFB greater than 5% and one of the following qualifying events: 1) 2 continuous AF episodes (LEAF) of 5 hours or longer; or 2) 2 rolling 24-hour periods in which cumulative AF duration is 5 hours or longer; or 3) 1 continuous AF episode (LEAF) of 5 hours or longer plus 1 rolling 24-hour period in which cumulative AF duration is 5 hours or longer
* Must have failed at least one prior therapy for AF
* Must have an AFSS greater than 3.
* CHA₂DS₂-VASc score of 1 or more for males and 2 or more for females and be on oral anticoagulant for at least 3 weeks prior to receiving the study medication.
* For participants with heart failure: NYHA Class I or II heart failure.

Key Exclusion Criteria:

* NYHA Class 3 or 4 heart failure.
* MI, ischemic stroke, or any clinically relevant venous thromboembolism within 3 months of screening.
* Unstable angina, percutaneous transluminal coronary angioplasty (PTCA), or CABG within 3 months of screening.
* Prolonged QTcF Interval with a normal QRS duration (\>500 ms with QRS ≤120 ms).
* Persistent AF (≥7 consecutive days or episodes \>23 hours). Those presenting with persistent AF at screening are eligible if they are scheduled to undergo first-time elective cardioversion, or second-time cardioversion
* Recent treatment with rhythm control medications (Class I or III Singh-Vaughan Williams) within five half-lives before screening (rate control drugs permitted) and amiodarone within 3 months prior to screening.
* Cardiac ablation procedures within 30 days of screening or participants who have scheduled an ablation procedure
* Severe end-organ disease

Conditions3

Interventions4

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