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

NCT07792239 | Recruiting Phase 2

• 3 other identifiers: CLN-2092025-523860-19-002025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

AF; Atrial Fibrillation; Paroxysmal Atrial Fibrillation; PAF

Outcome Measures

Primary Outcomes (1)

• Proportion of participants that have no long episodes of atrial fibrillation (LEAF) in the final month of treatment

  Proportion of participants that have no LEAF (uninterrupted episode of AF of 5 hours or longer in duration or cumulative duration of AF in any rolling 24-hour period that is 5 hours or longer) in the final month of treatment.

  24 weeks

Secondary Outcomes (3)

• Percent Change in Atrial Fibrillation Burden (AFB)

  24 weeks

• Change in percent of Atrial Fibrillation Severity Scale (AFSS) during final month of treatment.

  24 weeks

• Patient Global Impression of Change (PGI-C) during the final month of treatment

  24 weeks

Other Outcomes (7)

• Safety Assessment

  24 weeks

• Safety Assessment

  24 weeks

• Safety Assessments

  24 weeks

Study Arms (1)

Budiodarone

EXPERIMENTAL

Budiodarone is formulated as 200 mg capsules, to be administered as 1 capsule (200mg) twice a day (BID), 2 capsules (400 mg) BID, 3 capsules (600 mg) BID or 4 capsules (800 mg) BID.

Drug: Budiodarone 200 mg BID; Drug: Budiodarone 400 mg BID; Drug: Budiodarone 600 mg BID; Drug: Budiodarone 800 mg BID

Interventions

Budiodarone 200 mg BID DRUG

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

Budiodarone

Budiodarone 400 mg BID DRUG

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

Budiodarone

Budiodarone 600 mg BID DRUG

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

Budiodarone

Budiodarone 800 mg BID DRUG

Budiodarone is formulated as 200 mg capsules, to be administered as 4 capsules (800 mg) BID.

Budiodarone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xyra, LLC: lead
• Amarex Clinical Research: collaborator

Study Sites (4)

Oddział Kardiologiczny, Szpital Miejski Św. Wincentego a Paulo w Gdyni

Gdynia, 81-348, Poland

RECRUITING

Klinika Kardiologii

Krakow, 30-901, Poland

RECRUITING

EMED Centrum Usług Medycznych Ewa Śmiałek

Rzeszów, 35-205, Poland

RECRUITING

Klinika Kardiologii i Chorób Wewnętrznych Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy

Warsaw, 04-141, Poland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

budiodarone; BID protein, human

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter G Milner, MD, FACC

  Xyra, LLC

  STUDY DIRECTOR

Central Study Contacts

Frederic Heerinckx@xyra.us

CONTACT

+1 650 980-9972; fheerinckx@xyra.us

Sherry Toney

CONTACT

+1 650 980-9972; stoney@xyra.us

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants who meet the study entry criteria will be started on 200 mg budiodarone BID. The participants will return to the study site every 4 weeks and dose adjustments will follow the following algorithm. If no AF episode lasting 5 hours or longer is recorded and no rolling 24-hour period shows a cumulative AF burden of 5 hours or longer, the participant is classified as a monthly responder, and the budiodarone dose remains unchanged. If at least one AF episode of 5 hours or longer is observed, or if any rolling 24-hour period indicates a cumulative AF burden of 5 hours or longer, the participant is designated as a monthly non-responder, and the budiodarone dose is increased by 200 mg BID up to a maximum of 800 mg BID.

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 28, 2026
• Study Start: August 6, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4)