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The primary objectives of this study are to determine the effect of multiple doses of itraconazole on the single dose PK of ALXN2080, to determine the effect of multiple doses of fluconazole on the single dose PK of ALXN2080 (optional), and to determine the effect of multiple doses of carbamazepine on the single dose PK of ALXN2080.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | During Part 1, Period 1, participants will receive a single dose of ALXN2080 on the morning of Day 1. In Part 1, Period 2, participants will receive a dose of itraconazole orally once daily on the morning of Day 1 to Day 13. On the morning of Day 5, participants will be given a single dose of ALXN2080 co-administered with itraconazole. |
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| Part 2 (Optional) | Experimental | During Part 2, Period 1, participants will receive a single dose of ALXN2080 on the morning of Day 1. In Part 2, Period 2, participants will receive a single loading dose of fluconazole, followed by a dose of fluconazole qd on the morning of Day 2 to Day 10. On the morning of Day 4, participants will be given a single dose of ALXN2080 co-administered with fluconazole. |
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| Part 3 | Experimental | During Part 3, Period 1 participants will receive a single dose of ALXN2080 on the morning of Day 1. In Part 3, Period 2, participants will receive a dose of carbamazepine bid on the morning and evening of Day 1 to Day 3, followed by a dose of carbamazepine bid on the morning and evening of Day 4 to Day 6 and a dose of carbamazepine bid on the morning and evening of Day 7 to Day 23. On the morning of Day 19, participants will be given a single dose of ALXN2080 co-administered with carbamazepine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN2080 | Drug | Participants will receive ALXN2080 orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of ALXN2080 | Day 1 up to Day 24 | |
| Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of ALXN2080 | Day 1 up to Day 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Itraconazole | Day 4 up to Day 6 | |
| Area under the Curve for the Defined Interval Between Doses AUC(tau) of Itraconazole | Day 4 up to Day 6 | |
| Cmax of Fluconazole |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ruddington | NG11 6JS | United Kingdom |
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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| Itraconazole | Drug | Participants will receive Itraconazole orally. |
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| Fluconazole (AxMP) | Drug | Participants will receive Fluconazole orally. |
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| Carbamazepine (AxMP) | Drug | Participants will receive Carbamazepine orally. |
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| Day 2 up to Day 5 |
| AUC(tau) of Fluconazole | Day 2 up to Day 5 |
| Cmax of Carbamazepine | Day 2 up to Day 20 |
| AUC(tau) of Carbamazepine | Day 2 up to Day 20 |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Baseline up to Day 34 |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D015725 | Fluconazole |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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