Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809
Фаза 1
Завершено
NCT02068690
| 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 | 83 участн. |
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| Вмешательство | BI 425809 PfOS, Placebo PfOS, BI 425809 tablet |
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| Дата начала | 20.03.2014 |
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| Дата завершения | 10.09.2014 |
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| Публикация результатов | 5.05.2026 |
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Кратко
To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed
Number of Participants With Drug-related Adverse Events (AE)
SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention. · Participants
| SRD Part: Placebo | 3 Participants |
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| SRD Part: 0.5 mg BI 425809 | 1 Participants |
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| SRD Part: 1 mg BI 425809 | 2 Participants |
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| SRD Part: 2 mg BI 425809 | 1 Participants |
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| SRD Part: 5 mg BI 425809 | 2 Participants |
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| SRD Part: 10 mg BI425809 | 1 Participants |
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