Volume overload in heart failure
Conditions
Interventions
[Part A]
Suspension containing of OPC-131461 or placebo suspension will be orally administered as a single dose in a fasting state.
[Part B]
Suspension containing OPC-131461or placebo suspension will
Sponsors
Kim Seongryul
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 =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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Pharmacokinetic endpoint] Plasma concentration and plasma PK parameters of OPC-131461 [Pharmacodynamic endpoints] Urine volume, urine excretion rate, urine osmolality, urinary sodium excretion, urinary potassium excretion, urinary albumin excretion, urinary protein excretion, urinary creatinine excretion, urinary aquaporin 2 excretion, and urinary urea nitrogen excretion Fluid intake Fluid balance Free water clearance Serum osmolality, serum sodium concentration, serum potassium concentration, serum uric acid concentration, serum cystatin C concentration, and serum creatinine concentration Plasma arginine vasopressin (AVP) concentration, plasma renin activity, and plasma aldosterone concentration Creatinine clearance and estimated glomerular filtration rate Platelet aggregation [Safety endpoints] Clinical laboratory tests (hematology, biochemistry, urinalysis, and coagulation test) Vital signs (blood pressure, pulse rate, and body temperature) and dizziness Body weight 12-lead electrocardiogram (ECG) (safety evaluation) 12-lead ECG (QT evaluation) Adverse events | — |
Contacts
Public ContactCenter Drug Information
Otsuka Pharmaceutical Co., LTD.
Outcome results
None listed