Single and Multiple Oral Dose Trial of OPC-131461 in Healthy Adult Male Subjects
- Conditions
- Volume overload in heart failure
- Registration Number
- JPRN-jRCT2071200061
- Lead Sponsor
- Kim Seongryul
- Brief Summary
Single and multiple oral administrations of OPC-131461 in healthy adult male subjects, the mean Cmax and AUC increased in a dosedependent manner, and the median tmax and mean t1/2,z were 1.50 to 4.00 hours and 18.5 to 29.8 hours, respectively, suggesting that OPC-131461 was quickly absorbed and had a long half-life.The events with a high incidence were common to both parts of the trial and may have been due to the pharmacological effects of OPC-131461, but the severity of the events were all mild.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 82
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.
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, with a decrease in blood pressure upon standing (supine systolic blood pressure-standing systolic blood pressure) of >=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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method