A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood
Фаза 1
Завершено
NCT05945888
| 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 | 68 участн. |
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| Вмешательство | BI 3000202, Placebo matching BI 3000202 |
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| Дата начала | 25.07.2023 |
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| Дата завершения | 13.11.2023 |
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| Публикация результатов | 8.06.2026 |
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Кратко
The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.
SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator
From drug administration on Day 1 plus REP of 48 hours, up to 2 days. · Participants
| Single Rising Dose (SRD): Placebo Matching BI 3000202 | 1 Participants |
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| SRD: Dose 1 - BI 3000202 | 0 Participants |
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| SRD: Dose 2 - BI 3000202 | 0 Participants |
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| SRD: Dose 3 - BI 3000202 | 1 Participants |
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| SRD: Dose 4 - BI 3000202 | 0 Participants |
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| SRD: Dose 5 - BI 3000202 | 0 Participants |
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FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)
Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration · Nanomoles times hour per Liter
| Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R) | 901.43 ± NA Nanomoles times hour per Liter |
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| FE Part: Low Dose III BI 3000202 Fed (= Test T) | 768.45 ± NA Nanomoles times hour per Liter |
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| Geometric mean ratio (T/R) [%] | 85.25 (95% CI 71.74–101.30) |
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FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)
Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration · Nanomoles per Liter
| Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R) | 229.43 ± NA Nanomoles per Liter |
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| FE Part: Low Dose III BI 3000202 Fed (= Test T) | 219.06 ± NA Nanomoles per Liter |
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| Geometric mean ratio (T/R) [%] | 95.48 (95% CI 65.40–139.41) |
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