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RECRUITING
NCT07792239
PHASE2

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

Sponsor: Xyra, LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

Budiodarone 200 mg BID

Budiodarone is formulated as 200 mg capsules, to be administered as 1 capsule (200mg) twice a day (BID).

DRUG

Budiodarone 400 mg BID

Budiodarone is formulated as 200 mg capsules, to be administered as 2 capsules (400 mg) BID.

DRUG

Budiodarone 600 mg BID

Budiodarone is formulated as 200 mg capsules, to be administered as 3 capsules (600 mg) BID.

DRUG

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