Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05573724 | Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies | PHASE1 | COMPLETED | 16 | — | — | Nov 7, 2022 | May 17, 2024 | Jun 18, 2024 | 2 | Moldova, Romania |
The effect of Itraconazole on the AUCinf of AZD5305 will be assessed. The ratios of geometric means of test intervention (AZD5305 + Itraconazole; parent and metabolite\[s\], if applicable) relative to reference intervention (AZD5305 alone) of AUCinf will be presented.
The effect of Itraconazole on the AUClast of AZD5305 will be assessed. The ratios of geometric means of test intervention (AZD5305 + Itraconazole; parent and metabolite\[s\], if applicable) relative to reference intervention (AZD5305 alone) of AUClast will be presented.
The effect of Itraconazole on the Cmax of AZD5305 will be assessed. The ratios of geometric means of test intervention (AZD5305 + Itraconazole; parent and metabolite\[s\], if applicable) relative to reference intervention (AZD5305 alone) of Cmax will be presented.
The effect of Itraconazole on the PK of AZD5305 will be assessed.
The effect of Itraconazole on the PK of AZD5305 will be assessed.
The effect of Itraconazole on the PK of AZD5305 will be assessed.
The effect of Itraconazole on the PK of AZD5305 will be assessed.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Part A: The participants will receive a single oral dose of AZD5305 on Day 1, followed by a 2-day washout. Then Itraconazole will be dosed for 3 days \[BD\] on Day 4 and \[OD\] on Days 5 and 6, then a single oral dose of AZD5305 administered concurrently with Itraconazole on Day 7 and only Itraconazole on Days 8 to 12. Part B: Patients proceeding to Part B after completing Part A of the study will receive AZD5305 OD as monotherapy. |
| Name | Type | Description |
|---|---|---|
| AZD5305 | DRUG | In Part A, the participants will receive a single dose of AZD5305 on Day 1 and Day 7. In Part B, the participants will receive AZD5305 once daily. |
| Itraconazole | DRUG | In Part A, the participants will receive Itraconazole twice daily on Day 4 and once daily on Days 5-12 |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses. * Males and females aged ≥ 18 years at the time of screening. * Patients with documented evidence of locally advanced unresectable or metastatic solid tumours...