NL-OMON49615已完成不适用
Single-center, open-label, non-placebo-controlled, single-dose study in healthy male participants to determine the pharmacokinetics of BAY 1817080 oral solution (Part A) and to investigate the pharmacokinetics, metabolic disposition and mass balance of [14C]BAY 1817080 oral solution (Part B) - BAY 1817080 (P2X3 receptor antagonist) Mass Balance Study
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
- 14
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 99（—）
入选标准
- •1. Capable of giving signed informed consent as described in Appendix 10.1.4,
- •which includes compliance with the requirements and restrictions listed in the
- •ICF and in this protocol;
- •2. Ability to understand and follow study-related instructions;
- •3. Participant has signed the ICF before any study specific tests or procedures
- •4. Healthy male participant;
- •5. Age: 18 to 65 years (inclusive) at the time of informed consent and first
- •dose of study medication
- •For the complete overview see the protocol
排除标准
- •1. Presence or history of clinically relevant cardiovascular, central nervous
- •system (CNS), hepatic, hematopoietic disease, renal dysfunction, metabolic or
- •endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension,
- •seizures, or allergic skin rash;
- •2. Known hypersensitivity to the study drugs (active substances or excipients
- •of the preparations);
- •3. Known severe allergies, e.g., allergies to more than 3 allergens, allergies
- •affecting the lower respiratory tract (e.g., allergic asthma), allergies
- •requiring therapy with corticosteroids or significant non-allergic drug
- •4. Febrile illness within 1 week before study drug administration;
- •5. Current or recent (within 6 months) gastrointestinal disease that would be
- •expected to influence the absorption of drugs (i.e., a history of
- •malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis,
- •frequent occurrence of heartburn [more than once per week], or any
- •gastrointestinal surgical intervention [e.g. cholecystectomy]);
- •For the complete overview see the protocol
研究者
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