A Phase I Open-Label Study to Evaluate the Mass Balance and Pharmacokinetics of [14C]DS-1001b Following Single Oral Administration to Healthy Adult Male Subjects

Daiichi Sankyo Co., Ltd.0 个研究点目标入组 8 人开始时间: 2024年8月8日最近更新: 2024年10月30日

试验速览

暂无简介。

•Subjects who meet all of the following criteria are eligible for the study.
•Healthy Japanese adult males
•Aged 18 to 55 years (both inclusive) at the time of informed consent
•A body mass index (BMI) >=18.5 and <25.0 kg/m^2 at the time of screening test
•UGT1A1 EM (having no mutation of *6 and *28), or UGT1A1 PM (having either of *6/*6, *6/*28, or *28/*28)

•Having a history of stomach or intestinal surgery or disease that would potentially alter absorption and/or excretion of orally administered drugs (however, appendectomy and repair of pyloric stenosis are allowed)
•Having 3 days or less with at least one spontaneous defecation (bowel movement without purgative medicine, enema or stool extraction) during the 7 days prior to the screening test
•Having a history of hypersensitivity or being idiosyncratic (e.g., having penicillin allergy) to any drug
•Underwent administration of radiolabeled substances or exposure to diagnostic/therapeutic radiation (e.g., gastric X ray, computed tomography [CT] scans, positron emission tomography [PET], etc.) during the period from 12 months before study drug administration and until completion of the post-study examination or follow-up examination (however, chest X ray and dental radiography are allowed)

Mass balance and pharmacokinetics

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