A Relative Bioavailability and Food Effect Trial of OPC-131461 in Healthy Adult Male Subjects

Completed

• Conditions: Volume overload in heart failure

• Registration Number: jRCT2071210093
• Lead Sponsor: Otsuka Pharmaceutical Co., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-12
• Study Start: 2022-01-22
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

1. Healthy Japanese men at least 20 years and less than 40 years of age at the time of informed consent.
2. Body mass index (BMI = body weight [kg]/[height {m}]2) of >=18.5 kg/m2 to <25.0 kg/m2 (at screening).
3. Individuals who provide written consent prior to the commencement of any trial-related procedure and who are able to comply with the trial procedures in the opinion of the investigator or subinvestigator.

Exclusion Criteria

1. Clinically significant abnormalities are found on screening examinations (eg, a marked deviation from the normal range) or in the subject's medical history that, in the opinion of the investigator, subinvestigator, or sponsor, may pose a risk to the subject or affect the absorption, distribution, metabolism, or elimination of the investigational medicinal product. Such abnormalities include but are not limited to current or a history of cardiac, hepatic, renal, neurological, gastrointestinal, respiratory, hematological, and immunological conditions.
2. Systolic blood pressure of >140 mmHg or <100 mmHg or diastolic blood pressure of >90 mmHg or <50 mmHg at rest for at least 3 minutes in the supine position 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 12-lead ECG findings at screening, such as atrioventricular block, QRS interval of >120 msec, and QTcF interval of >=450 msec.
5. Any of the following hepatitis criteria is met: -Prior or current hepatitis B, or current hepatitis C. A positive test for hepatitis B surface antigen or hepatitis C virus antibody at screening. -Prior or current alcoholic hepatitis or non-alcoholic steatohepatitis.
6. Prior or current acquired immunodeficiency syndrome. A positive test for human immunodeficiency virus or syphilis or a positive polymerase chain reaction (PCR) test for SARS CoV 2 at screening.
7. History of serious mental disorders.

Study & Design

• Study Type: Interventional
• Study Design: crossover assignment

Primary Outcome Measures

Name	Time	Method
Relative BA arm		Differences in the mean natural-log-transformed values and two-sided 90% confidence intervals (CIs) for the plasma Cmax, AUC(infinity), and AUCt of OPC-131461 between the 2 formulations following administration of OPC-131461 suspension or OPC-131461 tablet in a fasting state
Food effect arm		Differences in the mean natural-log-transformed values and two-sided 90% CIs for the plasma Cmax, AUC(infinity), and AUCt of OPC-131461 between administration of OPC-131461in a fasting state and administration of OPC-131461 tablet in a fed states
Secondary Pharmacokinetic Endpoints		Plasma OPC-131461 concentration and plasma pharmacokinetic parameters of plasma OPC-131461
Safety		Clinical laboratory tests (hematology, blood chemistry, and urinalysis), vital signs (blood pressure, pulse rate, and temperature), body weight, 12-lead electrocardiography (ECG), and adverse events (AEs)