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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy participants.
This study will be an open-label, fixed sequence, Drug-Drug Interaction (DDI) study consisting of 3 periods.
The study will comprise:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD2389 and Itraconazole | Experimental | AZD2389 is dosed on days 1 and 6. Itraconazole is dosed on days 3,4,5,6,7, with the dose on day 6 coming after AZD2389. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2389 | Drug | AZD2389 is administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed drug concentration (Cmax) of AZD2389 | To assess the effect of itraconazole on the Cmax of AZD2389. | Day 1 to Day 8 |
| Area under concentration-timecurve from time zero to infinity (AUCinf) of AZD2389 | To assess the effect of itraconazole on the AUCinf of AZD2389. | Day 1 to Day 8 |
| Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD2389 | To assess the effect of itraconazole on the AUClast of AZD2389. | Day 1 to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent total body clearance (CL/F) of AZD2389 | To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole | Day 1 to Day 8 |
| Apparent volume of distribution based on the terminal phase (Vz/F) of AZD2389 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brooklyn | Maryland | 21225 | United States |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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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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| Itraconazole |
| Drug |
Itraconazole is administered orally |
|
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole |
| Day 1 to Day 8 |
| Terminal elimination half-life (t1/2λz) of AZD2389 | To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole. | Day 1 to Day 8 |
| Time to reach maximum observed concentration (tmax) of AZD2389 | To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole. | Day 1 to Day 8 |
| Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on Cmax (RCmax) of AZD2389 | To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole. | Day 1 to Day 8 |
| Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on AUClast (RAUClast) of AZD2389 | To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole. | Day 1 to Day 8 |
| Ratio of Test treatment (AZD2389 + itraconazole) to Reference (AZD2389) based on AUCinf (RAUCinf) of AZD2389 | To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole. | Day 1 to Day 8 |
| Renal Clearance (CLR) of AZD2389 | To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole. | Day 1 to Day 8 |
| Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae(t1-t2)) of AZD2389 | To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole. | Day 1 to Day 8 |
| Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe(t1-t2)) of AZD2389 | To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole. | Day 1 to Day 8 |
| Percent change from baseline in fibroblast activation protein (FAP) inhibition | To evaluate the pharmacodynamics (PD) of AZD2389 by assessment of inhibition of FAP activity in plasma after single oral dose of AZD2389 alone or in combination with itraconazole. | Day 1 to Day 8 |
| Number of participants with Adverse Events (AEs) | To assess the safety and tolerability of a single oral dose of AZD2389 alone or in combination with itraconazole in healthy participants. | From Screening (Day -29 to Day -2) up to 8 weeks |
| D010879 |
| Piperazines |