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This is a Phase 1, single-center, nonrandomized, open-label, 2-part, fixed-sequence, drug-drug interaction (DDI) study to assess the effect of multiple doses of itraconazole, a CYP3A4 enzyme inhibitor, on the single dose PK of AZD4205 in healthy adult subjects (Part A) and to assess the effect of multiple doses of carbamazepine, a CYP3A4 inducer, on the single dose PK of AZD4205 in healthy adult subjects (Part B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD4205 and carbamazepine | Experimental | Subjects in arm 1 will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with carbamazepine after the wash-out period. |
|
| AZD4205 and itraconazole | Experimental | Subjects in arm 2 will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with itraconazole after the wash-out period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4205 and carbamazepine | Drug | All subjects will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with carbamazepine after the wash-out period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of AZD4205 when dosed alone or coadministered with itraconazole (Part A) | up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole | |
| Time to reach maximum plasma concentration (tmax) of AZD4205 when dosed alone or coadministered with itraconazole (Part A) | up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole | |
| Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC0-t) when dosed alone or coadministered with itraconazole (Part A) | up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole | |
| Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with itraconazole (Part A) | up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole | |
| Maximum plasma concentration (Cmax) of AZD4205 when dosed alone or coadministered with carbamazepine (Part B) | up to 10 days after study drug administration | |
| Time to reach maximum plasma concentration (tmax) of AZD4205 when dosed alone or coadministered with carbamazepine (Part B) | up to 10 days after study drug administration | |
| Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC0-t) when dosed alone or coadministered with carbamazepine (Part B) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shirlian Xu | Dizal Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates, Inc. | Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| AZD4205 and itraconazole | Drug | All subjects will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with itraconazole after the wash-out period. |
|
| up to 10 days after study drug administration |
| Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with carbamazepine (Part B) | up to 10 days after study drug administration |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010879 | Piperazines |