A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants
1상
완료
NCT06370728
| 대상 질환 | Healthy |
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| 임상 단계 | 1상 |
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| 스폰서 | Eli Lilly and Company |
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| 상태 | 완료 |
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| 참여자 수 | 30 명 |
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| 중재(약물) | Orforglipron, Carbamazepine |
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| 시작일 | 2024년 5월 6일 |
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| 완료일 | 2024년 7월 23일 |
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| 결과 공개일 | 2026년 7월 17일 |
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요약
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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