A Study in Healthy Men to Test How BI 1569912 is Processed in the Body
Phase 1
Completed
NCT06520553
| Condition | Healthy |
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| Phase | Phase 1 |
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| Sponsor | Boehringer Ingelheim |
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| Status | Completed |
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| Enrollment | 8 participants |
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| Interventions | BI 1569912 (C-14), BI 1569912 (C-13) |
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| Start date | Aug 26, 2024 |
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| Completion date | Oct 3, 2024 |
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| Results posted | May 22, 2026 |
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Summary
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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