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

Sponsor
Xyra, LLC
Study ID
NCT07792239
Phase
PHASE2
Status
Recruiting
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Conditions

  • Atrial Fibrillation (AF)
  • Paroxysmal AF

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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 400 mg BID — DRUG
    Budiodarone is formulated as 200 mg capsules, to be administered as 2 capsules (400 mg) BID.
  • Budiodarone 600 mg BID — DRUG
    Budiodarone is formulated as 200 mg capsules, to be administered as 3 capsules (600 mg) BID.
  • Budiodarone 800 mg BID — DRUG
    Budiodarone is formulated as 200 mg capsules, to be administered as 4 capsules (800 mg) BID.

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Aug 6, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Budiodarone
    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.

Primary Outcome Measure

Proportion of participants that have no long episodes of atrial fibrillation (LEAF) in the final month of treatment [ Time Frame: 24 weeks ]

Central Contacts

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