A phase 1 trial to determine the safety of OPC-108459 administered to subjects with atrial fibrillation

A multi-center, parallel-group comparison, double-blind, placebo-controlled, randomized, trial to determine the safety, pharmacokinetics, and efficacy of OPC-108459 administered as a single intravenous dose to subjects with paroxysmal or persistent atrial fibrillation (Phase 1 trial)

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221673

Enrollment

Registered

2011-12-15

Start date

2011-12-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation

Interventions

investigational material(s) Generic name etc : OPC-108459 INN of investigational material : Therapeutic category code : 212 Antiarrhythmic agents Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed with a diagnosis with paroxysmal and persistent atrial fibrillation

Exclusion criteria

Exclusion criteria: Heart failure, complication of atrial flutter, history of myocardial infarction and angina pectoris, etc.

Design outcomes

Primary

Measure	Time frame
Safety Pharmacokinetics	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026