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Dose Escalation Study to Assess Safety, Tolerability, and Efficacy of Budiodarone Treatment With Non-permanent Atrial Fibrillation
Sponsor: Xyra, LLC
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.
Official title: A Multicenter, Open-Label, Dose Escalation Study of the Safety, Tolerability, and Efficacy of Budiodarone for the Treatment of Subjects With Non-permanent Atrial Fibrillation
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-08-06
Completion Date
2027-06-30
Last Updated
2026-08-28
Healthy Volunteers
No
Conditions
Interventions
Budiodarone 200 mg BID
Budiodarone is formulated as 200 mg capsules, to be administered as 1 capsule (200mg) twice a day (BID).
Budiodarone 400 mg BID
Budiodarone is formulated as 200 mg capsules, to be administered as 2 capsules (400 mg) BID.
Budiodarone 600 mg BID
Budiodarone is formulated as 200 mg capsules, to be administered as 3 capsules (600 mg) BID.
Budiodarone 800 mg BID
Budiodarone is formulated as 200 mg capsules, to be administered as 4 capsules (800 mg) BID.
Locations (4)
Oddział Kardiologiczny, Szpital Miejski Św. Wincentego a Paulo w Gdyni
Gdynia, Poland
Klinika Kardiologii
Krakow, Poland
EMED Centrum Usług Medycznych Ewa Śmiałek
Rzeszów, Poland
Klinika Kardiologii i Chorób Wewnętrznych Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy
Warsaw, Poland