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Verinurad ER8 formulation · 1 trial · 1 indication
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
| Arm | Type | Description |
|---|---|---|
| Treatment 1 | EXPERIMENTAL | During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state. |
| Treatment 2 | EXPERIMENTAL | During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state. |
| Treatment 3 | EXPERIMENTAL | During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state. |
| Treatment 4 | EXPERIMENTAL | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
| Treatment 5 | EXPERIMENTAL | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
| Name | Type | Description |
|---|---|---|
| Verinurad ER8 capsule formulation (fasted) | DRUG | Each participant will receive single-dose treatment of 12 mg verinurad ER8 capsule with 240 mL water, following an overnight fast of at least 10 hours. |
| Verinurad A-capsule formulation (fasted) | DRUG | Each participant will receive single-dose treatment of 12 mg verinurad A-capsule with 240 mL water, following an overnight fast of at least 10 hours. |
| Verinurad A-capsule formulation (fed) | DRUG | Each participant will receive single dose treatment of 12 mg verinurad A-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast). |
| Verinurad B-capsule formulation (fasted) | DRUG | Each participant will receive single-dose treatment of 12 mg verinurad B-capsule with 240 mL water, following an overnight fast of at least 10 hours. |
| Verinurad B-capsule formulation (fed) | DRUG | Each participant will receive single dose treatment of 12 mg verinurad B-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast). |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and female participants aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture. 3. Have a body mass index (BMI) between 18 and 30 kg/m2 an...
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Verinurad ER8 formulation is an extended-release capsule version of verinurad, a small molecule being developed by AstraZeneca PLC (ticker AZN) for chronic kidney disease. It is an investigational Phase 1 asset and has been studied in a relative bioavailability trial comparing formulations under fasted and fed conditions.
Verinurad ER8 formulation targets SLC22A12 and acts as an inhibitor of that transporter. SLC22A12 is also known as URAT1, a urate transporter involved in reabsorption of uric acid in the kidney. Inhibiting this target is the mechanism under study in chronic kidney disease.
Verinurad ER8 formulation is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating this extended-release capsule formulation in chronic kidney disease.
Verinurad ER8 formulation is in Phase 1 development. It is an investigational drug and is not approved for any indication. The Phase 1 program consists of one completed trial, with no active trials currently listed.
Verinurad ER8 formulation has been studied in NCT04024501, a completed Phase 1 trial titled A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed Condition. The trial enrolled 25 participants in Germany, including healthy volunteers, and used a randomized, controlled design.
Yes. Verinurad ER8 formulation is also known as the Verinurad ER8 capsule formulation (fasted). The fasted description refers to the dosing condition used in the bioavailability study, which compared formulations under both fasted and fed states.