NL-OMON46572已完成不适用
Single center, open-label, non-randomized, non-placebo-controlled study to investigate the metabolism, excretion pattern, mass balance, safety, tolerability and pharmacokinetics after single administration of 200 mg [14C]rogaratinib (oral solution) in healthy male subjects - Rogaratinib (BAY1163877) human mass balance study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer AG
- 入组人数
- 6
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
- •-Healthy male subjects
- •-21 to 65 years, inclusive
- •-BMI 18.5 and 32.0 kg/m2 (inclusive)
- •-Total body weight of 55 to 100kg (inclusive)
- •-non-smoking or light smokers (not more than 5 cigarettes daily)
- •-Use adequate contraception during the study and in the 3 months following dosing
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
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