Open label, non-randomized, non-placebo controlled Phase 1 study to investigate the mass balance, pharmacokinetics and metabolic disposition of [14C]BAY 3283142 in healthy male participants. - BAY 3283142 Human Mass Balance Study

Bayer0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Participant must be 18 to 55 years of age (both inclusive), at the time of
•signing the informed consent. Participants who are overtly healthy as
•determined by medical evaluation including medical history, physical
•examination, laboratory tests, and cardiac monitoring. Body mass index (BMI)
•within the range 18.0 and 29.9 kg/m2 (inclusive). Body weight equal or above 60

•Pre-existing diseases for which it can be assumed that the absorption,
•distribution, metabolism, elimination, and effects of the study interventions
•will not be normal. Known or suspected liver disorders (e.g. chronic or acute
•hepatitis) or disorders of bile secretion/flow (cholestasis, also history of
•it) with the exception of Morbus Meulengracht. Acute diarrhea or constipation
•within 14 days before the first intake of study intervention. Regular use of
•medicines within the last 14 days before the first study intervention
•administration. Participant will be excluded when he participated in another
•study with a radiation burden of: greater than 0.1 and less or equal to 1.1 mSv
•within 1 year prior to screening; greater than 1.1 and less or equal to 2.1 mSv
•within 2 years prior to screening; greater than 2.1 and less or equal to 3.1
•mSv within 3 years prior to screening, etc. (add 1 year per 1 mSv).

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