NL-OMON54965已完成不适用
Single dose escalation study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BAY 2413555 after oral dosing in healthy male participants in a randomized, single-blind, placebo-controlled, group-comparison design - A safety, absorption, elimination & activity study of BAY2413555
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer AG
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Healthy male participants
- •- Age: 18 to 50 years of age (inclusive), at the time of signing the informed
- •- Race: White
- •- Body mass index (BMI) within the range of 18-29.9 kg/m2 (inclusive) at the
- •time of screening.
- •- The informed consent must be signed before any study specific tests or
- •procedures are done
排除标准
- •1. Medical disorder, condition or history of such that would impair the
- •participant*s ability to take part in or complete this study in the opinion of
- •the investigator
- •2. A history of relevant or ongoing diseases such as:
- •- respiratory tract: e.g. asthma, any airway obstruction
- •- central nervous system: e.g. seizures, cerebrovascular malformations (e.g.
- •aneurysm), psychiatric or neurological disorders
- •- gastrointestinal tract: e.g. gallstones, any obstruction of the intestinum/
- •intestinal glands (e.g. pancreas), peptic ulcer
- •- urinary tract: e.g. nephrolithiasis, any obstruction of the urinary passage
- •3. Any condition for which it can be assumed that the absorption, distribution,
- •metabolism, elimination and effects of the study intervention(s) will not be
- •4. Known hypersensitivity to any study intervention (active substances or
- •excipients of the preparations) to be used in the study - including e.g.
- •non-investigational medicinal products, challenge agents, or rescue medication
- •5. Known severe allergies, e.g. allergies to more than 3 allergens, allergies
- •affecting the lower respiratory tract - allergic asthma, allergies requiring
- •therapy with corticosteroids, urticaria or significant non-allergic drug
- •For the complete overview, see the protocol
研究者
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