A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated
Фаза 1
Завершено
NCT04958252
| Заболевание | Healthy |
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| Фаза | Фаза 1 |
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| Спонсор | Boehringer Ingelheim |
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| Статус | Завершено |
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| Участники | 56 участн. |
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| Вмешательство | BI 1569912 |
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| Дата начала | 5.08.2021 |
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| Дата завершения | 30.10.2023 |
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| Публикация результатов | 22.05.2026 |
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Кратко
The main objectives of this trial are to investigate safety and tolerability of BI 1569912 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses. Secondary objective is the exploration of pharmacokinetics (PK) of BI 1569912.
SRD Part - Number of Subjects With Drug-related Adverse Events
From drug administration plus 48 hours (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours. · Participants
| SRD Part - Placebo | 0 Participants |
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| Single-rising Dose Part - BI 1569912 2.5 mg | 0 Participants |
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| Single-rising Dose Part - BI 1569912 5 mg | 0 Participants |
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| Single-rising Dose Part - BI 1569912 10 mg | 0 Participants |
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| Single-rising Dose Part - BI 1569912 20 mg | 0 Participants |
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MD Part - Number of Subjects With Drug-related Adverse Events
From first drug administration until last administration of study drug plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. · Participants
| Multiple Dose Part - Placebo | 1 Participants |
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| Multiple Dose Part - 20 mg BI 1569912 | 2 Participants |
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Evening PK Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration. · hours*nanomole/Liter
| Evening Pharmacokinetics Part - 5 mg BI 1569912 R | 892.68 ± NA hours*nanomole/Liter |
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| Evening Pharmacokinetics Part - 5 mg BI 1569912 T | 817.93 ± NA hours*nanomole/Liter |
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| Ratio of adjusted geometric means [%] | 91.63 (95% CI 89.46–93.84) |
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