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

NCT07792239 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-28

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)
  • Paroxysmal AF

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.

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • Xyra, LLC

    lead INDUSTRY

Principal Investigators

  • Peter G Milner, MD, FACC · Xyra, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-06
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07792239 on ClinicalTrials.gov