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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The purpose of this study is to assess the safety and tolerability of AZD3974 and characterize the pharmacokinetics (PK) of AZD3974 following oral administration to healthy participants, including participants of Japanese and Chinese descent.
This is a first in human, randomized, single-blind, placebo-controlled study. It consists of two parts.
Part A (single ascending dose - SAD): This study part will enroll six cohorts (plus two optional additional cohorts) of healthy participants (Part A1), three cohorts (plus one optional additional cohort) of healthy Japanese participants (Part A2) and one cohort (plus one optional additional cohort) of healthy Chinese participants (Part A3). Cohort 3 of Part A1 will be extended to evaluate the effect of food intake on the PK of AZD3974. In Part A (all cohorts), participants will receive a single dose of AZD3974 or placebo.
Part B (Multiple Ascending Dose - MAD): This study part will consist of four cohorts (plus two optional additional cohorts) of healthy participants (Part B1) and one cohort (plus one optional additional cohort) of healthy Japanese participants (Part B2). In all Part B cohorts, participants will receive multiple doses of AZD3974 or placebo.
Both Part A and Part B will comprise of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A1 (SAD) Cohort 1: AZD3974 (Dose 1) | Experimental | Healthy participants will receive a single dose of AZD3974 - Dose 1 |
|
| Part A1 (SAD) Cohort 2: AZD3974 (Dose 2) | Experimental | Healthy participants will receive a single dose of AZD3974 - Dose 2 |
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| Part A1 (SAD) Cohort 3: AZD3974 (Dose 3) (Food Effect Cohort) | Experimental | Healthy participants will receive two single doses of AZD3974 - Dose 3 |
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| Part A1 (SAD) Cohort 4: AZD3974 (Dose 4) | Experimental | Healthy participants will receive a single dose of AZD3974 - Dose 4 |
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| Part A1 (SAD) Cohort 5: AZD3974 (Dose 5) | Experimental | Healthy participants will receive a single dose of AZD3974 - Dose 5 |
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| Part A1 (SAD) Cohort 6: AZD3974 (Dose 6) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3974 | Drug | AZD3974 will be administered as an oral solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | To assess the safety and tolerability of AZD3974 following oral administration of single and multiple ascending doses in healthy participants, including Chinese and Japanese participants | Part A: Upto Day 7; Part A1 Cohort 3: Upto Day 10; Part B: Upto Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Plasma concentrations of AZD3974 | To characterize the plasma concentrations of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants. | Part A: Day 1 to Day 2; Part B: Day 1 to Day 9 |
| Part A1-Cohort 3: Plasma concentrations of AZD3974 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Glendale | California | 91206 | United States | |
| Research Site |
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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Healthy participants will receive a single dose of AZD3974 - Dose 6 |
|
| Part A1 (SAD) optional additional Cohort 7: AZD3974 | Experimental | Healthy participants will receive a single dose of AZD3974 |
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| Part A1 (SAD) optional additional Cohort 8: AZD3974 | Experimental | Healthy participants will receive a single dose of AZD3974 |
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| Part A1 (SAD) Cohort: Placebo | Placebo Comparator | Healthy participants will receive a single dose of matching placebo to AZD3974 |
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| Part A1 (SAD) Cohort 3: Placebo (Food Effect Cohort) | Placebo Comparator | Healthy participants will receive two single doses of matching placebo to AZD3974 |
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| Part A2 (SAD) Japanese Cohort 1: AZD3974 | Experimental | Healthy Japanese participants will receive a single dose of AZD3974 |
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| Part A2 (SAD) Japanese Cohort 2: AZD3974 | Experimental | Healthy Japanese participants will receive a single dose of AZD3974 |
|
| Part A2 (SAD) Japanese Cohort 3: AZD3974 | Experimental | Healthy Japanese participants will receive a single dose of AZD3974 |
|
| Part A2 (SAD) optional additional Japanese Cohort 4: AZD3974 | Experimental | Healthy Japanese participants will receive a single dose of AZD3974 |
|
| Part A2 (SAD) Japanese Cohort: Placebo | Placebo Comparator | Healthy Japanese participants will receive a single dose of matching placebo to AZD3974 |
|
| Part A3 (SAD) Chinese Cohort 1: AZD3974 | Experimental | Healthy Chinese participants will receive a single dose of AZD3974 |
|
| Part A3 (SAD) optional additional Chinese Cohort 2: AZD3974 | Experimental | Healthy Chinese participants will receive a single dose of AZD3974 |
|
| Part A3 (SAD) Chinese Cohort: Placebo | Placebo Comparator | Healthy Chinese participants will receive a single dose of matching placebo to AZD3974 |
|
| Part B1 (MAD) Cohort 1: AZD3974 | Experimental | Healthy participants will receive multiple doses of AZD3974 |
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| Part B1 (MAD) Cohort 2: AZD3974 | Experimental | Healthy participants will receive multiple doses of AZD3974 |
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| Part B1 (MAD) Cohort 3: AZD3974 | Experimental | Healthy participants will receive multiple doses of AZD3974 |
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| Part B1 (MAD) Cohort 4: AZD3974 | Experimental | Healthy participants will receive multiple doses of AZD3974 |
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| Part B1 (MAD) optional additional Cohort 5: AZD3974 | Experimental | Healthy participants will receive multiple doses of AZD3974 |
|
| Part B1 (MAD) optional additional Cohort 6: AZD3974 | Experimental | Healthy participants will receive multiple doses of AZD3974 |
|
| Part Bl (MAD) Cohort: Placebo | Placebo Comparator | Healthy participants will receive multiple doses of matching placebo to AZD3974 |
|
| Part B2 (MAD) Japanese Cohort 1: AZD3974 | Experimental | Healthy Japanese participants will receive multiple doses of AZD397 |
|
| Part B2 (MAD) optional additional Japanese Cohort 2: AZD3974 | Experimental | Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974 |
|
| Part B2 (MAD) Japanese Cohort: Placebo | Placebo Comparator | Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974 |
|
| Placebo | Other | Placebo will be administered as an oral solution. |
|
To assess the impact of food (fed) on the single-dose plasma concentrations of AZD3974 |
| Day 1 to Day 4 |
| Part A and Part B: Urine concentrations of AZD3974 | To characterize the urine concentration of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants. | Part A: Day 1; Part B: Day 1 and Day 7 |
| Part A1-Cohort 3: Urine concentrations of AZD3974 | To assess the impact of food (fed) on the single-dose urine concentrations of AZD3974 | Day 1 and Day 3 |
| Part A and Part B: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants | Part A: Day 1 to Day 2; Part B: Day 1 to Day 9 |
| Part A1-Cohort 3: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 to Day 4 |
| Part A: Area under concentration-time curve from time 0 to infinity (AUCinf) | To characterize the PK of AZD3974 following single ascending doses in healthy participants, including Chinese and Japanese participants | Day 1 to Day 2 |
| Part A1-Cohort 3: Area under concentration-time curve from time 0 to infinity (AUCinf) | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 to Day 4 |
| Part A and Part B: Maximum observed drug concentration (Cmax) | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants | Part A: Day 1 to Day 2; Part B: Day 1 to Day 9 |
| Part A1-Cohort 3: Maximum observed drug concentration (Cmax) | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 to Day 4 |
| Part A and Part B: Time to reach maximum observed concentration (tmax) | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants | Part A: Day 1 to Day 2; Part B: Day 1 to Day 9 |
| Part A1-Cohort 3: Time to reach maximum observed concentration (tmax) | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 to Day 4 |
| Part A and Part B: Terminal elimination half-life (t½λz) | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants | Part A: Day 1 to Day 2; Part B: Day 1 to Day 9 |
| Part A1-Cohort 3: Terminal elimination half-life (t½λz) | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 to Day 4 |
| Part A and Part B: Apparent total body clearance (CL/F) | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants | Part A: Day 1 to Day 2; Part B: Day 1 to Day 9 |
| Part A1-Cohort 3: Apparent total body clearance (CL/F) | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 to Day 4 |
| Part A and Part B: Apparent volume of distribution based on the terminal phase (Vz/F) | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants | Part A: Day 1 to Day 2; Part B: Day 1 to Day 9 |
| Part A1-Cohort 3: Apparent volume of distribution based on the terminal phase (Vz/F) | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 to Day 4 |
| Part A and Part B: Individual and cumulative amount of unchanged drug excreted into urine from time t0 to time tlast [Ae(0-last)] | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants | Part A: Day 1; Part B: Day 1 and Day 7 |
| Part A1-Cohort 3: Individual and cumulative amount of unchanged drug excreted into urine from time t0 to time tlast [Ae(0-last)] | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 and Day 3 |
| Part A and Part B: Individual and cumulative percentage of dose excreted unchanged in urine from time t0 to tlast [fe(0-last)] | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants | Part A: Day 1; Part B: Day 1 and Day 7 |
| Part A1-Cohort 3: Individual and cumulative percentage of dose excreted unchanged in urine from time t0 to tlast [fe(0-last)] | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 and Day 3 |
| Part A and Part B: Renal clearance (CLR) | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants | Part A: Day 1; Part B: Day 1 and Day 7 |
| Part A1-Cohort 3: Renal clearance (CLR) | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 and Day 3 |
| Part A and Part B: Mean Residence Time (MRT) | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants. | Part A: Day 1 to Day 2; Part B: Day 1 to Day 9 |
| Part A1-Cohort 3: Mean Residence Time (MRT) | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 to Day 4 |
| Part A and Part B: Time delay between drug administration and the first observed concentration (tlag) | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants. | Part A: Day 1 to Day 2; Part B: Day 1 to Day 9 |
| Part A1-Cohort 3: Time delay between drug administration and the first observed concentration (tlag) | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 to Day 4 |
| Part A and Part B: Time of last quantifiable concentration (tlast) | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants. | Part A: Day 1 to Day 2; Part B: Day 1 to Day 9 |
| Part A1-Cohort 3: Time of last quantifiable concentration (tlast) | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 to Day 4 |
| Part A and Part B: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1 t2)] | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants. | Part A: Day 1; Part B: Day 1 and Day 7 |
| Part A1-Cohort 3: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1 t2)] | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 and Day 3 |
| Part A and Part B: Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 - [fe(t1-t2)] | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants. | Part A: Day 1; Part B: Day 1 and Day 7 |
| Part A1-Cohort 3: Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 - [fe(t1-t2)] | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 and Day 3 |
| Part A and Part B: Cumulative amount of unchanged drug excreted into urine (Aeinf) | To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants. | Part A: Day 1; Part B : Day 1 and Day 7 |
| Part A1-Cohort 3: Cumulative amount of unchanged drug excreted into urine (Aeinf) | To assess the impact of food (fed) on the single-dose PK of AZD3974 | Day 1 and Day 3 |
| Part B: Area under concentration time curve in the dosing interval (AUCtau) | To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants | Day 1 to Day 9 |
| Part B: Observed lowest concentration before the next dose is administered: (Ctrough) | To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 9 |
| Part B: Accumulation ratio for AUC calculated as steady State AUCτ/First Dose AUCτ (Rac AUC) | To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants | Day 1 to Day 9 |
| Part B: Accumulation ratio for Cmax calculated as steady State Cmax/First Dose Cmax (Rac Cmax) | To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 9 |
| Part B: Temporal change parameter calculated as steady State AUCτ/First Dose AUCinf (TCP) | To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants. | Day 1 to Day 9 |
| Recruiting |
| Baltimore |
| Maryland |
| 21225 |
| United States |