A phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics and the Food Effect on the Safety and Pharmacokinetics of OPC-131066

A phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of OPC-131066 Administered in a Randomized, Parallel-group, Placebo-controlled, Double-blind Fashion and Evaluating the Food Effect on the Safety and Pharmacokinetics of OPC-131066 Administered in an Open-label, Crossover Fashion to Healthy Adult Male Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224712

Enrollment

122

Registered

2019-06-04

Start date

2019-06-17

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

healthy adult

Interventions

investigational material(s) Generic name etc : OPC-131066 INN of investigational material : - Therapeutic category code : 213 Diuretics Dosage and Administration for Investigational material : A singl

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Individuals with body mass index (BMI = body weight [kg]/[height{m}]2) of 18.5 kg/m2 to 25.0 kg/m2 (at screening)

Exclusion criteria

Exclusion criteria: 1) Clinically significant abnormalities found on screening examinations (eg,a marked deviation from the normal range) or from the subject's history and such abnormalities may potentially pose a risk to the subject or affect such variables as absorption, distribution, metabolism, and elimination of the drugs in the opinion of the investigator or subinvestigator. These abnormalities include but are not limited to cardiac, hepatic, renal, neurological, gastrointestinal, respiratory, hematological, and immunological conditions or their history. 2) Systolic blood pressure of over 140 mmHg or under 100 mmHg or diastolic blood pressure of over 90 mmHg or under 50 mmHg at rest for at least 3 minutes in the supine position, with a decrease in blood pressure upon standing (standing systolic blood pressure- supine systolic blood pressure) of over 20 mmHg at screening. 3) Pulse rate outside the range of 50 to 90 bpm at rest for at least 3 minutes in the supine position at screening. 4) Clinically significant electrocardiographic(ECG) findings from a 12-lead ECG examination performed at screening (Parts A, B, and C)For example, atrioventricular block, QRS interval of over 120 msec, and QTcF interval of over 450 msec.

Design outcomes

Primary

Measure	Time frame
safety Adverse events (AEs)	—

Secondary

Measure	Time frame
safety pharmacokinetics pharmacodynamics pharmacogenomics laboratory test	—

Countries

Japan

Outcome results

None listed

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