A phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of OPC-131066 Administered in a Randomized, Parallel-group, Placebo-controlled, Double-blind Fashion and Evaluating the Food Effect on the Safety and Pharmacokinetics of OPC-131066 Administered in an Open-label, Crossover Fashion to Healthy Adult Male Subjects

Otsuka Pharmaceutical Co., LTD.0 个研究点目标入组 122 人开始时间: 2019年6月4日最近更新: 2023年10月17日

适应症

试验速览

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•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.

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