A phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics and the Food Effect on the Safety and Pharmacokinetics of OPC-131066
- Conditions
- healthy adult
- Registration Number
- JPRN-jRCT2080224712
- Lead Sponsor
- Otsuka Pharmaceutical Co., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- Male
- Target Recruitment
- 122
Individuals with body mass index (BMI = body weight [kg]/[height{m}]2) of 18.5 kg/m2 to 25.0 kg/m2 (at screening)
1) Clinically significant abnormalities found on screening examinations (eg,a marked deviation from the normal range) or from the subject's history and such abnormalities may potentially pose a risk to the subject or affect such variables as absorption, distribution, metabolism, and elimination of the drugs in the opinion of the investigator or subinvestigator.
These abnormalities include but are not limited to cardiac, hepatic, renal, neurological, gastrointestinal, respiratory, hematological, and immunological conditions or their history.
2) Systolic blood pressure of over 140 mmHg or under 100 mmHg or diastolic blood pressure of over 90 mmHg or under 50 mmHg at rest for at least 3 minutes in the supine position, with a decrease in blood pressure upon standing (standing systolic blood pressure- supine systolic blood pressure) of over 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 electrocardiographic(ECG) findings from a 12-lead ECG examination performed at screening (Parts A, B, and C)For example, atrioventricular block, QRS interval of over 120 msec, and QTcF interval of over 450 msec.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Adverse events (AEs)
- Secondary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>pharmacodynamics<br>pharmacogenomics<br>laboratory test