A Single-center, Open-label, Randomized, Parallel-group Comparison Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the OPB-111077 Current Formulation Versus the Modified Formulation by Single Oral Administration in Healthy Adult Male Subjects (Phase 1)

Sanada Nobuhito0 个研究点目标入组 56 人开始时间: 2023年6月27日最近更新: 2024年4月23日

试验速览

暂无简介。

•1) Japanese males at least 18 years of age and below the age of 40 at the time of informed consent
•2) Subjects with a body mass index (BMI) between 18.5 and 25.0 kg/m2 (inclusive) at screening
•3) Subjects who are able to provide personally-signed informed consent prior to initiation of any trial-related procedures and who are judged by the investigator or subinvestigator to be capable of meeting all of the requirement of the trial

•1) Subjects with clinically significant abnormalities in the screening examination or in their medical history that could potentially pose a risk to the subject or affect such endpoints as the absorption, distribution, metabolism, or excretion of the drug as judged by the investigator or subinvestigator
•2) Subjects who fall under any of the following criteria for hepatitis
•-Subjects with a history or current symptoms of hepatitis B or current symptoms of hepatitis C, or who test positive for hepatitis B surface (HBs) antigen or hepatitis C virus (HCV) antibody at screening
•-Subjects with a history or current symptoms of alcoholic hepatitis or nonalcoholic steatohepatitis
•3) Subjects who have acquired immunodeficiency syndrome (AIDS) or a history of human immunodeficiency virus (HIV) infection, who test positive for HIV or syphilis at screening, or who have a positive polymerase chain reaction (PCR) test for SARS coronavirus 2 (SARS-CoV-2) at screening and at pre-admission)
•4) Subjects with a history or complication of a serious mental disorder
•5) Subjects with a history or complication of diabetes mellitus

发起方

Sanada Nobuhito