A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants
1期
已完成
NCT06370728
| 适应症 | Healthy |
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| 分期 | 1期 |
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| 申办方 | Eli Lilly and Company |
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| 状态 | 已完成 |
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| 受试者人数 | 30 人 |
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| 干预（药物） | Orforglipron, Carbamazepine |
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| 开始日期 | 2024年5月6日 |
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| 完成日期 | 2024年7月23日 |
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| 结果公布日 | 2026年7月17日 |
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摘要
The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Orforglipron
Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose) · nanograms*hours per milliliter(ng*h/mL)
| Orforglipron + Carbamazepine | 104 ± 26.6 nanograms*hours per milliliter(ng*h/mL) |
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| Orforglipron + Carbamazepine | 18.5 ± 41.7 nanograms*hours per milliliter(ng*h/mL) |
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PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron
Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose) · nanograms*hours per milliliter(ng*h/mL)
| Orforglipron + Carbamazepine | 93.4 ± 24.6 nanograms*hours per milliliter(ng*h/mL) |
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| Orforglipron + Carbamazepine | 15.8 ± 51.8 nanograms*hours per milliliter(ng*h/mL) |
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PK: Maximum Observed Concentration (Cmax) of Orforglipron
Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose) · nanograms per milliliter (ng/mL)
| Orforglipron + Carbamazepine | 4.97 ± 31.0 nanograms per milliliter (ng/mL) |
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| Orforglipron + Carbamazepine | 2.22 ± 47.3 nanograms per milliliter (ng/mL) |
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