Phase1 study of OPC-61815

A Single-center, Randomized, Double-blind (for OPC-61815 and Placebo), Placebo- and Moxifloxacin Positive-controlled, 4-Period Crossover Trial to Evaluate the Effect of Single Intravenous Administration of OPC-61815 at 16 and 32 mg on QT/QTc Interval in Healthy Male Subjects.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223877

Enrollment

Registered

2018-04-18

Start date

2018-04-18

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

Congestive heart failure

Interventions

investigational material(s) Generic name etc : OPC-61815 INN of investigational material : - Therapeutic category code : 213 Diuretics Dosage and Administration for Investigational material : 16mg or

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Body mass index (BMI) [body weight in kg / (height in m)2] of at least 18.5 kg/m2 and less than 25.0 kg/m2 as a result of at the screening examination 2) Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to start of any trial-related procedures and capable of complying with the procedures for this trial

Exclusion criteria

Exclusion criteria: 1) Subjects with a medical history of convulsive disorder, long QT syndrome (including family history), syncope during swimming, or any other type of syncope or cryptogenic loss of consciousness 2) Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia, hypocalcemia, etc) 3) Subjects with a family history of sudden death

Design outcomes

Primary

Measure	Time frame
pharmacodynamics QTcF difference between the OPC-61815 and placebo	—

Secondary

Measure	Time frame
pharmacodynamics 12-Lead Holter ECG parameters and ECG waveform patterns	—

Countries

Japan

Outcome results

None listed

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