A Study in Healthy Men to Test How BI 1569912 is Processed in the Body
1期
已完成
NCT06520553
| 适应症 | Healthy |
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| 分期 | 1期 |
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| 申办方 | Boehringer Ingelheim |
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| 状态 | 已完成 |
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| 受试者人数 | 8 人 |
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| 干预（药物） | BI 1569912 (C-14), BI 1569912 (C-13) |
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| 开始日期 | 2024年8月26日 |
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| 完成日期 | 2024年10月3日 |
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| 结果公布日 | 2026年5月22日 |
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摘要
The main objectives of this trial are: * To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T). * To investigate the absolute bioavailability of BI 1569912 as single oral solution dose, using a single, concomitant intravenous micro-tracer administration of BI 1569912 (C-13) (reference treatment, R)
Fraction Excreted in Urine as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (fe Urine,0-tz) of [14C]-Radioactivity
Up to 14 days. · Percentage of administered dose
| 10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) | 57.0 ± 10.9 Percentage of administered dose |
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Fraction Excreted in Faeces as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (fe Faeces,0-tz) of [14C]-Radioactivity
Up to 14 days. · Percentage of administered dose
| 10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) | 31.1 ± 62.9 Percentage of administered dose |
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Total Recovery of [14C]-Radioactivity
Up to 14 days. · Percentage of administered dose
| 10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) | 91.2 ± 12.7 Percentage of administered dose |
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