A drug-drug interaction trial of OPC-61815 and rifampicin in healthy male subject
- Conditions
- Congestive heart failure
- Registration Number
- JPRN-jRCT2080224955
- Lead Sponsor
- Otsuka Pharmaceutical Co., LTD.
- Brief Summary
Overall, there were no new safety concerns identified taking OPC-61815, either alone or in combination with rifampicin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 14
1) Japanese male subjects age 20 to 45 years, inclusive
2) Body Mass Index (BMI): at least 18.5 kg/m2 and less than 25.0 kg/m2
3) Subjects determined to have a genotype SLCO1B1 521T/T as a result of
genetic testing for OATP1B1
Subjects with a history of clinically significant abnormality, or for whom a clinically significant abnormality is observed in the results of the screening examination, for which the investigator, subinvestigator, or sponsor judges that the abnormality could place the subject at risk or affect evaluation of drug absorption, distribution, metabolism, or excretion. Such abnormalities include, but are not limited to, a history or current symptoms of cardiac, hepatic, renal, nervous, endocrine, gastrointestinal, respiratory, hematologic, and immune diseases/disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>Assessments for Pharmacokinetics
- Secondary Outcome Measures
Name Time Method safety<br>Assessments for Safety: adverse events (AEs), clinical laboratory tests, physical<br>examination findings, vital signs (temperature, blood pressure, and pulse rate), body<br>weight, and 12-lead electrocardiogram (ECG)