A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood
Фаза 1
Завершено
NCT06041438
| 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 | 14 участн. |
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| Вмешательство | BI 1584862, Itraconazole |
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| Дата начала | 29.09.2023 |
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| Дата завершения | 10.11.2023 |
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| Публикация результатов | 3.06.2026 |
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Кратко
The main objective of this trial is to investigate the effect on the exposure of BI 1584862 in plasma when given as single dose together with multiple doses of itraconazole (Test, T) as compared to BI 1584862 when given alone as oral single dose (Reference, R).
Area Under the Concentration-time Curve of BI 1584862 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Within 3 to 4 h before and up to 3 days after BI 1584862 administration. · hour*nanomole/Liter
| BI 1584862 (R) | 999.27 ± NA hour*nanomole/Liter |
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| BI 1584862 + Itraconazole (T) | 7981.53 ± NA hour*nanomole/Liter |
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| Ratio of adjusted geometric means [%] | 798.74 (95% CI 688.62–926.46) |
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Maximum Measured Concentration of BI 1584862 in Plasma (Cmax)
Within 3 to 4 h before and up to 3 days after BI 1584862 administration. · nanomole/Liter
| BI 1584862 (R) | 408.11 ± NA nanomole/Liter |
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| BI 1584862 + Itraconazole (T) | 801.07 ± NA nanomole/Liter |
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| Ratio of adjusted geometric means [%] | 196.29 (95% CI 174.54–220.75) |
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