NL-OMON51347已完成不适用
A phase I, open-label trial to investigate metabolism, pharmacokinetics (following a mass balance design) and absolute bioavailability of BI 690517 (C-14) after oral and intravenous administration in healthy male subjects - Study to test how BI 690517 is taken up and handled by the body
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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 64（—）
入选标准
- •1. Healthy male subjects according to the assessment of the investigator, as
- •based on a complete medical history
- •including a physical examination, vital signs (BP, PR), 12-lead ECG, and
- •clinical laboratory tests
- •2. Age of 18 to 55 years (inclusive)
- •3. BMI of 18.5 to 29.9 kg/m2 (inclusive)
- •4. Signed and dated written informed consent in accordance with ICH-GCP and
- •local legislation prior to admission
- •to the trial
排除标准
- •1. Any finding in the medical examination (including BP, PR or ECG) deviating
- •from normal and assessed as
- •clinically relevant by the investigator
- •2. Repeated measurement of systolic blood pressure outside the range of 90 to
- •140 mmHg, diastolic blood
- •pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of
- •40 to 100 bpm
- •3. Any laboratory value outside the reference range that the investigator
- •considers to be of clinical relevance
- •4. Any evidence of a concomitant disease assessed as clinically relevant by the
- •investigator
- •5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
- •immunological or hormonal disorders
- •Further criteria apply
研究者
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