A Study in Healthy Men to Test How BI 764198 is Processed in the Body
1期
已完成
NCT05863130
| 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 | 24 人 |
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| 干预（药物） | BI 764198 (C-14) (approach 1), BI 764198 (C-14) (approach 2) |
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| 开始日期 | 2023年5月3日 |
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| 完成日期 | 2023年11月9日 |
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| 结果公布日 | 2026年6月3日 |
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摘要
The main objective of this trial is to investigate the basic pharmacokinetics of BI 764198 and its metabolites, total radioactivity including mass balance, excretion pathways and metabolism following oral administration to healthy male volunteers of a single oral dose of BI 764198 (C-14) in i) a classical hADME approach and ii) a hADME microtracer approach.
Mass Balance Recovery of Total Radioactivity in Urine and Faeces: Amount Excreted Within the Time Interval From 0 to the Time of the Last Quantifiable Data Point as a Percentage of the Administered Dose (fe0-tz) for Urine and Faeces.
Urine and feces sample collection: 48 hours before and up to 725 hours after drug administration. The details are mentioned in the description section. · Percentage of dose excreted
| Cohort 1: Classical hADME | 73.7 ± 6.23 Percentage of dose excreted |
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| Cohort 2: Microtracer hADME | 73.2 ± 6.04 Percentage of dose excreted |
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| Cohort 1: Classical hADME | 22.9 ± 10.7 Percentage of dose excreted |
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| Cohort 2: Microtracer hADME | 22.4 ± 10.6 Percentage of dose excreted |
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