A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood
Фаза 1
Завершено
NCT06367153
| 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 | 18 участн. |
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| Вмешательство | BI 1569912, Repaglinide, Midazolam, Bupropion |
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| Дата начала | 15.05.2024 |
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| Дата завершения | 20.08.2024 |
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| Публикация результатов | 22.05.2026 |
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Кратко
The main objective of this trial is to investigate the effect of multiple oral doses of BI 1569912 on the pharmacokinetics of a single oral dose of repaglinide, midazolam and bupropion (i.e. sensitive CYP2C8, CYP3A4 and CYP2B6 substrates).
Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter. · hour*picomole/liter
| Repaglinide 0.5 mg (R1) | 21882.61 ± NA hour*picomole/liter |
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| Repaglinide 0.5 mg + BI 1569912 (T1) | 27332.41 ± NA hour*picomole/liter |
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| Adjusted gMean ratio [%] | 124.90 (95% CI 115.78–134.75) |
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Area Under Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter. · hour*picomole/liter
| Midazolam 2 mg (R2) | 57471.40 ± NA hour*picomole/liter |
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| Midazolam 2 mg + BI 1569912 (T2) | 69127.73 ± NA hour*picomole/liter |
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| Adjusted gMean ratio [%] | 120.28 (95% CI 108.66–133.15) |
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Area Under the Concentration-time Curve of S-bupropion in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter. · hour*nanomole/liter
| Bupropion 150 mg (R3) | 302.02 ± NA hour*nanomole/liter |
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| Bupropion 150 mg + BI 1569912 (T3) | 312.11 ± NA hour*nanomole/liter |
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| Adjusted gMean ratio [%] | 103.34 (95% CI 93.98–113.64) |
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