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This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD2389 following single and multiple dose administration (SAD/MAD) to healthy participants.
This is a Phase I, First In Human (FIH), randomized, single-blind, placebo-controlled, single and multiple ascending dose study in healthy male and/or female participants of non-childbearing potential including healthy participants of Chinese and Japanese ethnicity performed at a single center.
The study consists of 2 parts: Part A and Part B. Part A has been planned to be conducted with 78 participants and Part B has been planned to be conducted with 32 participants.
Each participant in Part A and Part B will be involved in the study for up to 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Part A1 - AZD2389 dose 1/placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
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| Cohort 2: Part A1 - AZD2389 dose 2/placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
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| Cohort 3: Part A1 - AZD2389 dose 3 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
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| Cohort 4: Part A1 - AZD2389 dose 4 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
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| Cohort 5: Part A1 - AZD2389 dose 5 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2389 | Drug | Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part A (SAD): Number of participants with adverse events (AE) and serious adverse events (SAE) | To assess the safety and tolerability of AZD2389 following oral administration of single ascending doses in healthy participants, including Japanese and Chinese participants. | Day ≤ -28 (Only SAE), Day -1 (Only SAE), Days 1 and 2, Day 8 Post-dose (± 1 day) |
| Part B (MAD): Number of participants with AE and SAE | To assess the safety and tolerability of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day ≤ -28 (Only SAE), Day -1 (Only SAE), Days 1 to 12, Day 17 (± 1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A (SAD): Plasma concentrations of AZD2389 | To characterize the plasma concentration of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Urine concentrations of AZD2389 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | 91206 | 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.
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 environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Placebo-controlled
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| Cohort 6: Part A1 - AZD2389 dose 6 oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389. |
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| Cohort 7: Part A2 - AZD2389 dose 7 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
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| Cohort 8: Part A2 - AZD2389 dose 8 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
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| Cohort 9: Part A2 - AZD2389 dose 9 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
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| Cohort 10: Part A3 - AZD2389 dose 10 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
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| Cohort 11: Part B1 - AZD2389 dose 11 /placebo oral administration | Experimental | A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. |
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| Cohort 12: Part B1 - AZD2389 dose 12 /placebo oral administration | Experimental | A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. |
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| Cohort 13: Part B1 - AZD2389 dose 13 /placebo oral administration | Experimental | A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. |
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| Cohort 14: Part B2- AZD2389 dose 14/placebo oral administration | Experimental | A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. |
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| Placebo | Drug | Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
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To characterize the urine concentration of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. |
| Day 1 and Day 2 |
| Part A (SAD): Terminal rate constant (λz) | To characterize the λz of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] | To characterize the Ae(t1-t2) of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Area under plasma concentration time curve from zero to infinity (AUCinf) | To characterize the AUCinf of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Dose normalized AUCinf (AUCinf/D) | To characterize the AUCinf/D of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) | To characterize the AUClast of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Dose normalized AUClast (AUClast/D) | To characterize the AUClast/D of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Apparent total body clearance of drug (CL/F) | To characterize the CL/F of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Maximum observed plasma (peak) drug concentration (Cmax) | To characterize the Cmax of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Dose normalized Cmax (Cmax/D) | To characterize the Cmax/D of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Renal clearance (CLR) | To characterize the CLR of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)] | To characterize the fe(t1-t2) of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Mean residence time (MRTinf) | To characterize the MRTinf of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Apparent terminal elimination half-life (t½λz) | To characterize the t½λz of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Time of last quantifiable concentration (tlast) | To characterize the tlast of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Time to reach peak or maximum observed concentration (tmax) | To characterize the tmax of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Apparent volume of distribution based on the terminal phase (Vz/F) | To characterize the Vz/F of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part A (SAD): Change in PD biomarkers over time | To characterize the percentage change in PD biomarkers over time compared to baseline of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants. | Day 1 and Day 2 |
| Part B (MAD): Plasma concentrations of AZD2389 | To characterize the plasma concentration of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Urine concentrations of AZD2389 | To characterize the urine concentration of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 and Days 10 to 12 |
| Part B (MAD): Terminal rate constant (λz) | To characterize the λz of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] | To characterize the Ae(t1-t2) of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 and Days 10 to 12 |
| Part B (MAD): Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) | To characterize the AUClast of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Area under the concentration-time curve in the dose interval (AUCtau) | To characterize the AUCtau of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Dose normalized AUCtau (AUCtau/D) | To characterize the AUCtau/D of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Dose normalized AUClast (AUClast/D) | To characterize the AUClast/D of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Apparent total body clearance of drug (CL/F) | To characterize the CL/F of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 and Days 10 to 12 |
| Part B (MAD): Renal clearance (CLR) | To characterize the CLR of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 and Days 10 to 12 |
| Part B (MAD): Maximum observed plasma (peak) drug concentration (Cmax) | To characterize the Cmax of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Dose normalized Cmax (Cmax/D) | To characterize the Cmax/D of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Observed lowest concentration before the next dose is administered(Ctrough) | To characterize the Ctrough of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)] | To characterize the fe(t1-t2) of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 and Days 10 to 12 |
| Part B (MAD): Accumulation ratio for AUC (Rac AUC) | To characterize the Rac AUC of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Accumulation ratio for Cmax (Rac Cmax) | To characterize the Rac Cmax of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Time to reach peak or maximum observed concentration (tmax) | To characterize the tmax of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Apparent terminal elimination half-life (t½λz) | To characterize the t½λz of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Apparent volume of distribution based on the terminal phase (Vz/F) | To characterize the Vz/F of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 12 |
| Part B (MAD): Change in PD biomarkers over time | To characterize the percentage change in PD biomarkers over time compared to baseline of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants. | Days 1, 2, 4, 8, and 10 |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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