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This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of ADC189 in healthy adults.
Participants in this study will complete screening assessments within 14 days before the first dose of ADC189. Participants will be admitted to the clinical pharmacology center (CPC) and complete 2 periods of treatments. On Day 1 and 26, each participant will receive a single oral dose of ADC189 (45mg), under fasting condition On Day 22, all participants will receive oral doses of itraconazole 200 mg (bid), after meal. From Day 23 to Day 25, and Day 26-D39, participants will receive itraconazole 200 mg(qd). Blood and safety assessments will continue for 336-hours after dosing on Day 1 and Day 26. Participants will receive a telephone follow-up on D47 (±3) days for a final visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADC-189 and itraconazole | Experimental | Part 1: Single dose of ADC-189 Part 2: Itraconazole with single dose of ADC-189 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADC-189 and Itraconazole | Drug | Part 1: Day 1, fasting condition, 45 mg ADC189, administered orally Part 2: Day 22, 200 mg itraconazole bid, taken orally after meals. Day 23-Day 25, 200 mg itraconazole was taken orally after meals. Day 26, 45 mg ADC-189 and 200 mg itraconazole was taken orally after meals. Day 27-Day 39, 200 mg itraconazole was taken orally after meals. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC[0-∞] of ADC-189 | Pharmacokinetics (PK) parameter: Area under the curve from time 0 hour to ∞ | Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40 |
| Cmax of ADC-189 | PK parameter: Maximum observed concentration | Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40 |
| AUC[0-t] of ADC-189 | PK parameter: Area under the curve from time 0 to 336 hour | Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40 |
| Adverse events (AEs) | Number of subjects reporting AEs | Day 1 to Day 43 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huan Zhou | The First Affilicated Hospital of Bengbu Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affilicated Hospital of Bengbu Medical University | Bengbu | Anhui | 233004 | China |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
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| D010879 |
| Piperazines |