A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women
Фаза 1
Завершено
NCT07542847
| Заболевание | Healthy Volunteers |
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| Фаза | Фаза 1 |
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| Спонсор | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| Статус | Завершено |
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| Участники | 24 участн. |
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| Вмешательство | OPC-167832, Itraconazole, Carbamazepine |
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| Дата начала | 19.09.2022 |
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| Дата завершения | 18.11.2022 |
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| Публикация результатов | 5.06.2026 |
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Кратко
The purpose of this trial is to assess the potential for cytochrome P450 (CYP)-mediated drug-drug interactions (DDIs) with OPC-167832. The study is conducted in 2 parts: Part 1 assesses the potential effect of the CYP3A inhibitor itraconazole on the metabolism of OPC-167832 and Part 2 assesses the potential effect of the CYP3A inducer carbamazepine on the metabolism of OPC-167832 in healthy adult participants.
Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832
Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15. · nanograms per milliliter (ng/mL)
| OPC-167832 | 81.0 ± 29.3 nanograms per milliliter (ng/mL) |
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| OPC-167832 and Itraconazole | 144 ± 66.7 nanograms per milliliter (ng/mL) |
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| Geometric Mean Ratio (GMR) | 1.723 (95% CI 1.410–2.106) |
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Part 2: Cmax of OPC-167832
Predose and up to 168 hours postdose on Day 1; and Predose and up to 168 hours postdose on Day 25. · ng/mL
| OPC-167832 | 95.1 ± 36.6 ng/mL |
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| OPC-167832 and Carbamazepine | 95.8 ± 32.9 ng/mL |
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| GMR | 1.07 (95% CI 0.926–1.236) |
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Part 1: Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of OPC-167832
Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15. · Nanograms*hours per milliliter (ng*h/mL)
| OPC-167832 | 2310 ± 898 Nanograms*hours per milliliter (ng*h/mL) |
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| OPC-167832 and Itraconazole | 4490 ± 2390 Nanograms*hours per milliliter (ng*h/mL) |
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| GMR | 1.82 (95% CI 1.568–2.113) |
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