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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The purpose of this study is to assess the pharmacokinetics (PK) and safety of AZD2389 when administered alone and in combination with quinidine in healthy participants.
This is a 2-way cross-over study to evaluate the effect of quinidine on the PK of AZD2389.
The study will include 2 Treatments - Treatment A - AZD2389 Treatment B - AZD2389 + quinidine
The study will comprise -
Participants will be randomized to one of the 2 treatment sequences -
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence AB | Experimental | Participants will receive a single dose of Treatment A (AZD2389) in Period 1 and a single dose of Treatment B (AZD2389 + quinidine) in Period 2. |
|
| Sequence BA | Experimental | Participants will receive a single dose of Treatment B (AZD2389 + quinidine) in Period 1 and a single dose of Treatment A (AZD2389) in Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2389 | Drug | AZD2389 will be administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on maximum observed plasma concentration (RCmax) | To assess the effect of quinidine on the PK of AZD2389. | Day 1 to Day 10 |
| Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on area under concentration-time curve from time 0 to infinity (RAUCinf) | To assess the effect of quinidine on the PK of AZD2389. | Day 1 to Day 10 |
| Ratio of Test treatment (AZD2389 + quinidine) to Reference treatment (AZD2389) based on area under concentration-time curve from time 0 to the last quantifiable concentration (RAUClast) | To assess the effect of quinidine on the PK of AZD2389. | Day 1 to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent total body clearance (CL/F) of AZD2389 | To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine. | Day 1 to Day 10 |
| Volume of distribution (apparent) following extravascular administration (based on 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 shared.
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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 rerefer 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 environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| Quinidine |
| Drug |
Quinidine will be administered orally. |
|
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine. |
| Day 1 to Day 10 |
| Terminal elimination half-life (t1/2λz) of AZD2389 | To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine. | Day 1 to Day 10 |
| Time to reach maximum observed concentration (tmax) of AZD2389 | To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine. | Day 1 to Day 10 |
| Maximum observed plasma concentration (Cmax) of AZD2389 | To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine. | Day 1 to Day 10 |
| Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD2389 | To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine. | Day 1 to Day 10 |
| Area under concentration-time curve from time zero to infinity (AUCinf) of AZD2389 | To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine. | Day 1 to Day 10 |
| Renal Clearance (CLR) of AZD2389 from plasma | To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine. | Day 1 to Day 10 |
| Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe[t1-t2]) of AZD2389 | To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine. | Day 1 to Day 10 |
| Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2]) of AZD2389 | To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine. | Day 1 to Day 10 |
| Percent change from baseline in fibroblast activation protein (FAP) inhibition | To assess 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 quinidine. | Baseline, Day 1 to Day 10 |
| 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 quinidine in healthy participants. | From Screening (Day -28 to Day -2) to Follow-up visit (upto 8 weeks) |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011802 | Quinidine |
| ID | Term |
|---|---|
| D002930 | Cinchona Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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