Volume overload in heart failure
Conditions
Interventions
[Relative bioavailability (BA) arm]
Subjects will receive single oral administration of OPC-131461 at 20 mg (suspension or 5-mg tablet x 4) in a fasting state.
[Food effect arm]
Subjects will receive
Sponsors
Matsumaru Takehisa
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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 90 mmHg or 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Pharmacokinetic Endpoints: 1) 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 2) 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) | — |
Contacts
Public ContactCenter Drug Information
Otsuka Pharmaceutical Co., LTD.
Outcome results
None listed